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Allergan Aesthetics Breast Implants - recalled due to Increased risk of BIA-ALCL, USA

June 1, 2020 11:00 PM

United States

Allergan Aesthetics Breast Implants - recalled due to Increased risk of BIA-ALCL, USA

Company name: Allergan Aesthetics
Brand name: BIOCELL
Product recalled: Breast Implants
Reason of the recall: Increased risk of BIA-ALCL
FDA Recall date: June 01, 2020
Recall details: Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since July 2019 when the BIOCELL® recall was announced, robust efforts were made to reach patients, however, the Company is still seeking to directly contact all U.S. BIOCELL® patients that have not yet been notified. This is due to incomplete device tracking data for approximately 52,000 BIOCELL® breast implant units.

It is important to note the United States Food and Drug Administration (FDA) has made the following recommendation, "If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider."

Allergan Aesthetics will launch a multi-channel campaign which will include digital and social media advertisements further informing patients of the voluntary recall and directing them to Allergan Aesthetics' www.BIOCELLinformation.com website for education on how to identify their implant type and register their implants.

"Allergan Aesthetics is committed to patient safety and we are continuing to make every effort to make sure that each and every patient is made aware of the BIOCELL® recall, and knows their implant type and implant history," said John Maltman, Vice President of Medical Affairs at Allergan Aesthetics.

If patients are not aware of the BIOCELL® recall previously announced on July 24, 2019, and do not know the type of implant that they have in place or their implant history, they should either:
- Go to www.BIOCELLinformation.com to reach out to Allergan Aesthetics to determine if the company has their implant information.
- Contact their surgeon or hospital where they received implants to determine if the surgeon or hospital has records of their implant information.

Patients who know that they have an Allergan implant, and may not have participated in device tracking previously, or who need to update their information on www.BIOCELLinformation.com. The website will inform them how to register for device tracking, which is strongly advised for all patients, and answer any questions they may have. Patients with BIOCELL® implants or tissue expanders or a history of BIOCELL® implants or tissue expanders should go to www.BIOCELLinformation.com to learn about the BIOCELL® recall, symptoms of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), the importance of breast self-examination and the need for regular breast implant monitoring.

"We are determined to make sure every woman has the information they need related to the BIOCELL® voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system. Patient education is a priority. We have partnered with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) on major initiatives to raise awareness regarding the importance of breast implant tracking," said Carrie Strom, Senior Vice President AbbVie and President Global Allergan Aesthetics.

About the GLOBAL BIOCELL® Recall On July 24, 2019 Allergan initiated a voluntary global recall of its BIOCELL® breast implants and tissue expanders. Allergan has continued a global basis to ensure that patients and health care professions are notified about the BIOCELL® recall. The Company issued global press releases and distributed letters directly to healthcare professionals regarding the recall.

To generate awareness and provide a resource for patients, the Company launched a dedicated website, www.BI- OCELLinformation.com, to help patients identify their breast implants and to provide information and resources related to the risk of BIA-ALCL.

Allergan Aesthetics, an AbbVie company will continue to work closely with global regulatory authorities and societies and patient advocacy groups to provide important BIOCELL® information to patients and health care professionals regarding the voluntary recall.

More information on BIA-ALCL: BIA-ALCL is not breast cancer—it is a type of non-Hodgkin's lymphoma (cancer of the immune system). At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with BIOCELL® textured breast implants. However, BIA-ALCL is a serious condition and
can lead to death, especially if not diagnosed early or treated promptly.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Medical Devices
United States

Related Reports

September 22, 2020 12:00 AM

“Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: BD Alaris System Hardware
Reason of the recall: Potential for four hardware situations that may result in the infusion pump not operating as expected
FDA Recall date: September 21, 2020
Recall details: Three Recall... See Mores Designated as Class I by FDA; One Designated as Class II BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on  previously announced voluntary recalls of the BD Alaris™ System. Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. This FDA classification does not change the guidance BD provided in the company’s Aug. 4th recall announcements to customers. BD initiated the voluntary recalls to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations.

The four recalls include:  Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits(Recall 1 – Class I):
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion, interruption of infusion or inability to titrate medication.

Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits(Recall 2 – Class I):
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress, potentially resulting in a delay to the start of infusion or interruption of infusion.

BD Alaris™ Syringe Module Model 8110 and PCA Module Model 8120(Recall 3 - Class I):
The Alaris PC unit may display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion or over-infusion.

BD Alaris™ EtCO2 Module model 8300 channel error(Recall 4 – Class II)
Infusion pump component defect may result in interruption of patient monitoring.

Customers should review and follow the instructions in each of the recall letters listed above. Affected Products:

- Recall 1:  BD Alaris™ PC Unit model 8015 (manufactured from April 7, 2017 to present)
PC Unit Front Case with Keypad Replacement Kits:
TC10008389  ASSY CASE FRONT W/KEYPAD 8015LS
TC10010217  ASSY FRT CASE W/ KEYPAD 8015 M2
TC10012515  ASSY FR CASE W/ KEYPAD 8015 M2
TC10013702  ASSY, CASE, FRONT W/KEYPAD, 8015LS
TC10013664  ASSY FR CASE W/ KEYPAD 8015 M2

- Recall 2:  BD Alaris™ Pump Module Model 8100 (manufactured from December 1, 2016 to January 23, 2019)
Pump Module Door Assembly Replacement Kits (labeled with a date prior to January 25, 2019)
Affected part numbers: 49000239; 49000346; 49000438; 49000439

- Recall 3: BD Alaris™ Syringe Module Model 8110 (manufactured from March 1, 2010 to present)
BD Alaris™ PCA Module Model 8120 (manufactured from March 1, 2010 to present)
Syringe/PCA Sizer Sensor Replacement Kit (manufactured from March 1, 2010 to present)
Affected part number: 12278652 

- Recall 4: Alaris™ EtCO2 Module, Model 8300 (manufactured from January 5, 2018 to January 4, 2019)

Note that some affected devices may be branded under the CareFusion name. Customer inquiries related to this action should be addressed to BD’s Recall Support Center at 888-562-6018 or SupportCenter@bd.com. FDA MedWatch Reporting Adverse reactions/events experienced with the use of either of these products should also be reported to the FDA's MedWatch Program.

Check the full recall details on fda.gov

Source: FDA
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Reported By Iwaspoisoned.com User

September 1, 2020 5:05 PM

“Company name: Becton, Dickinson and Company
Brand name: Alaris
Product recalled: Alaris Infusion Pump
Reason of the recall: Hardware issues may cause the infusion pump to not operate as expected
FDA Recall date: September 01, 2020
Recall details: Majority of June 30 Recall Designated as Class I... See MoreRecall by FDA
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System.

Three of the situations described in this recall, which BD announced on June 30, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

This FDA classification does not change the guidance BD provided in the company's June recall announcement to customers.

BD initiated the voluntary recall to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations. The four situations include:
- Damaged Inter-Unit Interface (IUI) Connectors (Situation 1 – Class I)
- Broken elements on Alaris™ Pump Module platen (Situation 2 – Class I)
- Improperly secured PC unit Battery (Situation 3 – Class I)
- Dim LED Segment(s) on the Alaris™ modules (Situation 4 – Class II)

Customers should review and follow the instructions in the recall letter: www.bd.com/en-us/support/recall-notifications/recall-notification-for-alaris-system-infusion-pump-hardware

Check the list of affected Products on the link below. Note that some affected devices may be branded under the CareFusion name. Customer inquiries related to this action should be addressed to BD's Recall Support Center at 888-562-6018 or SupportCenter@bd.com.

Check the full recall details on fda.gov

Source: FDA
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Reported By Iwaspoisoned.com User

July 8, 2020 5:00 PM

“Company name: Endologix® Inc.
Brand name: Ovation
Product recalled: Ovation iX system
Reason of the recall: A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer.
FDA Recall date: July 08, 2020
Recall details: Company Announcem... See Moreent Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA as a Class 1 recall. No physical product removal of the product is planned or needed. Correction Z-2263-2020 was issued in May 2020 to current users of the Ovation iX system and informs users of a material weakness adjacent to the polymer fill channel that may become compromised during pressurization with liquid polymer. The clinical sequelae associated with polymer leaks may be systemic or aneurysm related. All lots/serial numbers, not yet implanted, of the following models are in the scope of the correction:
Check the full recall details on fda.gov
Source: FDA
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Reported By Iwaspoisoned.com User

July 8, 2020 4:00 PM

“Company name: CME America
Brand name: BodyGuard
Product recalled: Infusion System Administration Set (infusion set)
Reason of the recall: Use of the pump system potentially could cause over-infusion or under-infusion of therapy
FDA Recall date: July 08, 2020
Recall details: PRNewswire/ - CME Am... See Moreerica, a wholly owned subsidiary of BD (Becton, Dickinson and Company), announced a voluntary recall for all CME America BodyGuard® Infusion System Administration Sets (infusion sets) used with the company's BodyGuard® infusion pumps—that were distributed beginning May 2016 (see complete impacted product list below).  This action was initiated on June 16, 2020. As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing.

This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification (bd.com Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm. Based on those test results CME America is providing additional information and customer actions regarding its previous recall to include all infusion sets used with the BodyGuard® infusion pump distributed beginning May 2016.

CME America has defined four categories of impacted infusion sets based on delivery inaccuracy variability, two of which (Category A and B) can continue to be used in accordance with the instructions in the recall letter (bd.com CME America also announced on April 27, 2020, the decision to suspend distribution of the BodyGuard® infusion pumps and to remove all existing products from the U.S. market. CME America will work with customers to address the latest expanded infusion set recall and will continue to maintain continuity of care during the COVID-19 pandemic. Until such time that the BodyGuard® pumps have been removed from the market, CMEA will supply accessories and infusion sets in "Category A" and "Category B" to support the infusion pumps, and customers can continue to use the products in accordance with the Operator's Manual and the additional mitigations outlined in the customer letter.

Affected Product Types:

- BodyGuard BodySet
- BodyGuard Microset with Needleless Adaptor
- BodyGuard Microsets
- BodyGuard Microset w/ Non-Vented Spike Connector
- BodyGuard set with Female Luer
- BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer
- BodyGuard Microsets with Filter
- Standard BodySet with Needleless Connectors
- BodyGuard Microset with Filter and Manual Priming Valve
- CMExpress Microbore Sets
- BodyGuard Microset with Male Luer Connectors
- CMExpress Needleless Y Site Microbore Set

Check the full recall details on fda.gov

Source: FDA
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Reported By Iwaspoisoned.com User

June 24, 2020 6:00 PM

“Company name: Chengdu Ai Qin E-commerce Co., Ltd
Brand name: TTDeye
Product recalled: Colored contact lenses
Reason of the recall: Distributed without FDA clearance may pose health risk
FDA Recall date: June 24, 2020
Recall details: On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiate... See Mored a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. The company has received no complaints to date.

These colored contact lenses were sold through the company website and shipped directly to the customer from 08/05/2019 - 10/11/2019. The recalled products were manufactured in August 2018 and may be identified by name of the product and the date of manufacture, “2018-08”, found on the package label. The following products are being recalled:

- TTDeye. Black Starshine. Lot code: B16112100
- TTDeye. Diamonds Starlight. Lot code: B16112203
- TTDeye. Flower. Lot code: Brown. Lot code: B16112210
- TTDeye. Flower Grey. Lot code: B16112231
- TTDeye. Radial. Lot code: Brown. Lot code: B16112109
- TTDeye. Radial Pink. Lot code: B16112110
- TTDeye. Devil Red. Lot code: B16112201

If you have received this product, immediately cease use and contact the company via online chat at www.ttdeye.com between 9AM and 6PM (GMT+8) or contact the company via email at info@ttdeye.com (24 hours) for further information.

Chengdu Ai Qin E-commerce Co., Ltd is notifying its customers by email and is arranging for return/replacement of all recalled colored contact lenses.

Chengdu Ai Qin E-commerce Co., Ltd is voluntarily recalling these contact lenses after becoming aware of the problem. Chengdu Ai Qin E-commerce Co., Ltd has notified the FDA of this action.

Check the full recall details on fda.gov

Source: FDA
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Reported By Iwaspoisoned.com User

April 29, 2020 7:00 PM

“Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall... See Moredetails: CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By Iwaspoisoned.com User

April 21, 2020 2:00 PM

“Company name: Trividia Health, Inc.
Brand name: TRUE METRIX
Product recalled: TRUE METRIX® AIR Blood Glucose Meter
Reason of the recall: Incorrect factory-set unit of measure
FDA Recall date: April 21, 2020
Recall details: Trividia Health, Inc. today announced it is initiating a nationwide vol... See Moreuntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging. The company has determined that one (1) isolated TRUE METRIX AIR Blood Glucose Meter was packaged into a TRUE METRIX Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death.

There is one (1) affected TRUE METRIX AIR meter with serial number TA1548753 that was packaged into a TRUE METRIX Blood Glucose Meter Kit with the Lot number KW0135 and with UDI # (01)00021292006075(17)200831(10)KW0135(21)TA1548753. It has been determined that this kit was distributed nationwide in the United States in February 2019. Trividia Health has not received any reports of patient injury or an adverse event related to this voluntary recall.

If you have the affected TRUE METRIX AIR meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the affected TRUE METRIX AIR meter at no charge.

Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.
Notifications will be sent to US pharmacies, durable medical equipment providers and distributors who may have received this device from Trividia’s customer. Patient safety is a top priority at Trividia Health.

The company has notified the U.S. Food and Drug Administration (FDA) of this voluntary product recall and is working with the customer who received the affected meter to quickly resolve this matter. Users within the USA may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.

Check the full recall details on fda.gov

Source: FDA
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Reported By Iwaspoisoned.com User

April 3, 2020 2:01 PM

“Company name: Becton, Dickinson, and Company
Brand name: BD Alaris
Product recalled: BD Alaris System PC Units and Modules
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: March 10, 2020
Recall details: BD (Becton, Dickinson and Company), a leading global medical... See Moretechnology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System regarding software for the PC Unit and certain modules. BD has notified customers affected by this recall, and there is no change to those recall instructions.This recall, which BD announced on Feb. 4, 2020, has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA) and has been associated with medical device reporting (MDR) submissions. This FDA classification does not change the guidance BD provided in the company’s February recall announcement to customers.BD initiated the voluntary recall to notify customers of five issues where the infusion pump may not operate as expected and provide corrections and mitigations to protect patient safety. The five items include: Software errors related to System Error Code 255-XX-XXX;
Delay options programming;
Low Battery Alarm Failure;
Keep vein open (KVO)/End of Infusion alarms priority;
Use errors related to Customer Concentrations Programming.
Customers should review and follow the instructions in the recall letter:bd.com/alaris-system-software-recall.As previously communicated, BD is committed to seeking clearance of a comprehensive 510(k) filing for the Alaris™ System, which will remediate the issues identified in the Feb. 4, 2020 recall notification.In the interim, BD is providing important user actions in the recall notification letter to help mitigate the potential risks until these software issues are fully remediated. BD has also created a dedicated team of clinical consultants to support training for health care providers. For more information and to review all of the available resources provided by BD, please visit: bd.com/alaris-system-software-recall.Affected ProductsBD Alaris™ System PC Unit Model 8000, software versions 9.5 and prior
BD Alaris™ System PC Unit Model 8015, software versions 12.1.0 and prior
BD Alaris™ Pump Module Model 8100, software versions 12.1.0 and prior
Alaris™ Syringe Module Model 8110, software versions 12.1.0 and prior
Alaris™ PCA Module Model 8120, software versions 12.1.0 and prior
Note that some affected devices may be branded under the CareFusion name.
Check the full recall details on fda.gov
Source: FDA
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Reported By Iwaspoisoned.com User

April 3, 2020 2:01 PM

“Company name: Advanced Bionics
Brand name: HiRes Ultra and Ultra 3D
Product recalled: Cochlear implants
Reason of the recall: Reports of hearing performance degradation
FDA Recall date: March 10, 2020
Recall details: Advanced Bionics (AB), a global leader in developing advanced cochlear implant... See Moresystems, announced today that it has begun notifying regulatory authorities that it will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients.AB's priority is to ensure that all cochlear implant recipients and health care providers have the information they need to understand this situation and that they receive the necessary support. Existing recipients of HiRes Ultra and Ultra 3D may continue to use their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or other health care provider. In addition, we will begin the notification process for device recipients worldwide, where allowed, to make them aware of the potential issue. This voluntary action is being taken in an abundance of caution in response to recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of the more than 16,000 recipients of these implants, less than 0.5% have been explanted for this reason. Please note that this device-related issue may manifest in performance degradation that could require revision surgery. The only potential for patient harm are the risks associated with a surgery. AB has identified factors that contribute to the clinical symptoms leading to explant and hearing performance degradation. This information will be provided to health care professionals and recipients in geographies that allow. As of February 11th, in the small number of cases that have been explanted, fluid ingress at the electrode has occurred leading to interruption of stimulation. The hermetic seal of the implant case has been shown to be intact. In our efforts to continually improve our products and in response to early reports of this issue AB has developed several improvements to the device to address the issue (new version). AB has received regulatory approval from the FDA in the US and TUV SUD in Europe for these improvements. AB is in the process of submitting these improvements to additional global regulatory agencies. AB plans to distribute products in these geographies as soon as approvals are obtained. AB will continue to distribute the HiRes 90K Advantage cochlear implant as well as the new version of HiRes Ultra and Ultra 3D based on market availability.Previous generations of AB cochlear implants and external sound processors and accessories are not included in the scope of this voluntary field action. AB's primary concern is the safety and hearing performance of our recipients as well as the reliability of our products. AB continues to take all necessary corrective and preventative efforts to address this unforeseen occurrence.
Check the full recall details on fda.gov
Source: FDA
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Reported By Iwaspoisoned.com User

An employee got Covid-19, Dude's Steak House, 2126 Illinois St, Sidney, NE 69162, United States

Dude's Steak House, 2126 Illinois St, Sidney, NE 69162, United States

September 24, 2020 12:00 PM

“An employee tested positive for the coronavirus and other employees were identified as close contacts.

Source: newschannelnebraska.com See Less
Reported By Iwaspoisoned.com User

Recent Interesting Reports

September 16, 2020 9:38 PM

“The FSIS announced the recall of approximately 6,890 pounds of ready-to-eat (RTE) chicken salad products by Willow Tree Poultry Farm, Inc due to misbranding and an undeclared allergen. The products may contain walnuts, a known allergen, which are not declared on the product labels. There have been n... See Moreo confirmed reports of adverse reactions due to consumption of these products to date.

FSIS advises consumers not to eat the recalled products and to throw them away or return them to the place of purchase. The RTE chicken salad product labeled as “Classic Chicken Salad” may actually contain “White Meat Cranberry Walnut Chicken Salad” and was produced on Sept. 2, 2020. The products subject to recall bear establishment number “EST. P-8827” inside the USDA mark of inspection. These items were shipped to retail locations in Connecticut, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, Rhode Island, Vermont and Virginia. The following products are subject to recall:

- 15-oz. clear, plastic containers labeled as “Willow Tree Premium White Meat CHICKEN SALAD Classic” with a sell by date of “9/30/20” and a time stamp of 13:00:00 through 17:00:00 on the containers’ cellophane lid.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS
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Reported By SafelyHQ.com User

September 5, 2020 12:01 PM

“Company name: CorgioMed LLC
Brand name: Leafree
Product recalled: Hand sanitizer
Reason of the recall: Product is labeled as edible alcohol.
FDA Recall date: September 03, 2020
Recall details: CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within e... See Morexpiry to the consumer level.  The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.  The labeling of this product as ‘edible alcohol’ may promote this behavior. The product is used as a hand sanitizer and is packaged in 100 ml (UPC #6970495860325), 300 ml (UPC #69705860318) and 500 ml (UPC #6970495860301) bottles. 

Product was distributed Nationwide via CorgioMed website. CorgioMed LLC is notifying its distributors and customers by email and is arranging for return or disposal of all recalled products. Distributors and Consumers with questions regarding this recall can contact CorgioMed LLC by emailing to: contact@corgiomed.comor phone: 301-978-3898 from September 1st to September 30th, 2020. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 1, 2020 6:14 PM

“Company name: The Protein Shoppe, LLC
Brand name: Red-E
Product recalled: Red-E male enhancement tablet
Reason of the recall: Product contains undeclared sildenafil
FDA Recall date: September 01, 2020
Recall details: Company Announcement The Protein Shoppe, LLC is voluntarily recalling all lots... See Moreof “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction.

The presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that is life threatening and could result in serious adverse health consequences. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date The Protein Shoppe, LLC has not received any reports of adverse events related to this recall. The product, Red-E (Male Enhancement tablet), is marketed as a male enhancement nutritional supplement, the product is a scored octagonal tablet with “Red” embossed on either side of the score line on one side of the tablet which is contained in small plastic bag with a black label stapled to it, UPC. The Red-E pill was sold online at the website: www.rgvproteinshoppe.com.

The Protein Shoppe, LLC is notifying its customers with this press release and is arranging for return of all recalled products. Consumers that have The Red-E pill (male enhancement tablet), which is being recalled, should stop using and return to place of purchase. Consumers with questions regarding this recall can contact The Protein Shoppe by phone at 956-687-3539, Monday through Friday from 10 AM to 6 PM CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 14, 2020 10:41 AM

“I was do discussed I took one bite of my cheeseburger There was a long black curly hair wrapped into all around the burger it wasn't just a little piece of hair it was long and curly very bad turned me off from eating there now and I ate there lots it was on 09/05/2020 @ 2:46pm I took it back to the... See Morem rite away. I haven't posted the picture .. yet but feel like I should People shouldn't have to check and look at ther food especially from a place like this should n able to trust that ther nothing in there that shouldn't b why are they not wearing hair nets!? I watched the girls making the food in the back no one is wearing hair nets See Less
Reported By SafelyHQ.com User

August 31, 2020 4:00 PM

“Company name: Mylan N.V.
Brand name: Mylan
Product recalled: Tranexamic Acid and Amiodarone HCl injections
Reason of the recall: Vials potentially packaged in incorrect cartons
FDA Recall date: August 31, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan In... See Morestitutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials.

These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals. To date, Mylan has not received any reports of adverse events related to this recall.

Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety. If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function.

If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events. Amiodarone HCl Injection, USP is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled batch information is as follows:

NDC #: 67457-153-09
Material Description: Amiodarone HCl Injection, USP
Strength: 450 mg/9 mL
Carton Size: 10 x 9 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

NDC #: 67457-197-10
Material Description: Tranexamic Acid Injection, USP
Strength: 1000 mg/10 mL
Carton Size: 10 x 10 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. Wholesalers and hospital/clinic pharmacies that have product which is being recalled should stop use/further distribution or dispensing.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 10, 2020 5:00 PM

“Company name: Medek, LLC
Brand name: M
Product recalled: M Hand Sanitizer Alcohol Antiseptic 80%
Reason of the recall: Contains Methanol and may be Sub-Potent for Ethanol
FDA Recall date: September 10, 2020
Recall details: Medek, LLC is voluntarily recalling all lots of M Hand Sanitizer Alcoh... See Moreol Antiseptic 80% 128 oz/3,785 mL to the consumer level. FDA analysis found the M Hand Sanitizer to contain methanol and be sub-potent for ethanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. In addition, the use of sub-potent hand sanitizer products can have adverse health consequences related to lack of efficacy and increased risk of infections. To date, Medek, LLC. has not received any reports of adverse.

The recalled product is used as a hand sanitizer for hand washing to decrease bacteria on the skin when soap and water are not available. The recalled Hand Sanitizer is packaged in a one (1) gallon (128 oz/3,785 mL) High-density polyethylene (HDPE) plastic bottle, NDC 75432-001-02. The recalled Hand Sanitizer was distributed directly to walk-in customers in Alamo, TX, between the dates of 04/17/2020 to 05/22/2020.

Medek, LLC is notifying its customers/distributors by recall letter and consumers via this press release. We are also notifying our distributors, who will help notify their customers by phone calls, emails, and/or mailed letters and is arranging for return of all recalled Hand Sanitizer. Consumers, distributors, and retailers that have recalled products should stop use or distribution and return to place of purchase. Consumers with questions regarding this recall can contact Medek, LLC at (956) 800-4366 (Monday to Friday from 9 am to 5 pm CST).

Consumers should contact their physician or healthcare provider if they experience any problem that may be related to the use of this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 11, 2020 4:00 PM

“Company name: Goodie Girl Tribeca LLC
Brand name: Goodie Girl
Product recalled: Goodie Girl GF Magical Animal Crackers
Reason of the recall: May Contain Undeclared Wheat
FDA Recall date: September 11, 2020
Recall details: Goodie Girl Tribeca LLC announced today it is voluntarily recalling 389... See Morecases of a single date code of 7 oz. Goodie Girl Magical Animal Crackers, with a “best by” date of Jan 11, 21A3, after learning that the product may contain undeclared wheat ingredients. People who have an allergy or severe sensitivity to wheat run the risk of allergic reaction if they consume the product contained in the recalled boxes. There has been an individual with a wheat allergy that was treated for a wheat allergen reaction.

This recall affects only 389 cases of the following product, which were distributed in retail stores nationwide:
- Description; Goodie Girl GF Magical Animal Crackers
UPC# 8-5598700395-3
Size; 7 Ounces
Best By Date; Jan 11, 2021
Distributed between 4/17/2020 – 5/7/2020

This recall does not apply to any other “best by” dates, sizes or varieties of Goodie Girl Tribeca LLC. This recall was initiated in cooperation with the FDA and the third-party co-packer that produced the product. Product with this particular “best by” date was shipped and distributed by Goodie Girl Tribeca to its customers' warehouses located in Virginia, Pennsylvania, Georgia, New Hampshire, California. Consumers seeking a refund or additional information may contact info@goodiegirl.com or call 201-941-2000 9am – 5pm est.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 1, 2020 4:38 PM

“The FSIS announced the recall of approximately 1,202 pounds of ready-to-eat (RTE) chicken salad product by Ukrop’s Homestyle Foods due to misbranding and an undeclared allergen. The product may contain almonds, a known allergen, which are not declared on the product label.

The RTE chicken salad i... See Moretem was produced on August 26, 2020. The following product is subject to recall:

- 15-oz. round plastic containers containing “Ukrop’s Chicken Salad” with a sell by date of “09/02/20”.

The product subject to recall bears establishment number “P-19979” inside the USDA mark of inspection. These items were shipped to retail locations in North Carolina, Ohio, Virginia, and West Virginia. The problem was discovered after the firm received a consumer complaint reporting that the product contained almonds.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some product may be in retailer and consumers’ refrigerators. Retailers who have obtained these products are urged not to sell them. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. Consumers and members of the media with questions about the recall can contact Susan Rowe, Executive Administrator, Ukrop’s Homestyle Foods, at (804) 340-3050.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS
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Reported By SafelyHQ.com User

Insects in Food, Italist Pizza Pasta Bar, проспект Соборності, Kyiv, Ukraine

Italist Pizza Pasta Bar, проспект Соборності, Kyiv, Ukraine

September 5, 2020 12:03 PM

“Midgets in restaurant flying over my food, disgusting, waiter said it’s “nature” See Less
Reported By SafelyHQ.com User

September 3, 2020 7:00 PM

“Company name: AJR Trading LLC
Brand name: bio aaa
Product recalled: Hand Sanitizer
Reason of the recall: Possible presence of methanol
FDA Recall date: September 03, 2020
Recall details: AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currentl... See Morey in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests. However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, AJR Trading has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer to reduce bacteria when soap and water is not available and is packaged in 480 mL plastic bottles UPC 7502272121085.  AJR Trading is recalling lot 20DF8307, expiration date April 2022. The product can be identified by the images below. Product was distributed in Miami beginning in April 2020. AJR Trading is notifying its customers by phone calls, e-mails, and letters.  AJR Trading is arranging for refund and destruction of recalled products.

Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer, which is being recalled, should stop using or distributing the products immediately and mail the products to AJR Trading at the following address for refund: 814 Ponce de Leon Blvd, suite 218. Coral Gables, FL. 33134. Consumers with questions regarding this recall can contact AJR Trading by phone insert 305-302-8416 or e-mail to ajrtrading15@gmaill.com Monday to Friday from 10:00 am to 5:00 pm Central Time.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User