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Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially weakened elastic, USA

April 19, 2021 9:01 PM

United States

Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a nationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be found using the following link: Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA Consumers who have: Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or timestamp 6 should stop the distribution and use of these and return them to Tenacore LLC.
Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between July 2020 and Feb 2020, should be inspected per the instructions described below to ensure that your device is not impacted. If it is, please return your device to Tenacore LLC.
Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July 2020 through Feb 2021. The following products have been recalled:
Check the full recall details on fda.gov
Source: FDA

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

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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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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 SafelyHQ.com User

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 SafelyHQ.com User

October 29, 2020 12:00 PM

“Company name: Baxter International Inc.
Brand name: Sigma Spectrum
Product recalled: Infusion Pumps
Reason of the recall: Deviations from the specified cleaning methods may impair infusion pump
FDA Recall date: October 29, 2020
Recall details: Baxter International Inc. announced today it has is... See Moresued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may impair infusion pump functionality and performance. Baxter previously communicated this information to customers directly in a Safety Alert on April 1, 2020 and subsequently via an Urgent Device Correction notification on August 28, 2020.

Deviations from the cleaning methods described in product-specific Operator’s Manuals may lead to residue buildup or corrosion of the electrical pins (e.g. depressed pins) on the infusion pump rear case and battery electrical contacts. This could result in notifications that the user should check the battery, or that batteries are not charging or holding their charge. If a device has residue buildup or corrosion, and is running solely on battery power, the pump may shut down without alarming or alerting the user. An undetected or abrupt discontinuation in medication delivery may lead to a delay or interruption of intended treatment. Depending on various factors, including the medication being infused, the volume and rate of the infusion, the route of administration, and patient status and comorbidities, this could result in serious adverse health consequences or death.

To date, Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion. In addition to adhering to the cleaning instructions provided in the Operator’s Manuals for the products listed below, Baxter is instructing customers to assess the rear case electrical pins and battery electrical contacts for residue buildup or corrosion and depressed pins. Baxter is also recommending to have backup devices readily available when infusing critical medications. Additionally, the infusion pumps should be connected to AC power when possible to prevent battery depletion.

Finally, Baxter will be clarifying the Instructions for Use (IFU) to recommend a routine inspection to identify signs of residue buildup, corrosion and depressed pins. Once completed, Baxter will issue a written notification to inform customers of the availability of the updated IFU, which will be accessible in Baxter’s Global Technical E-Service Center: service.baxter.com .

Check the full recall details on fda.gov

Source: FDA
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January 11, 2021 1:00 PM

“Company name: Boston Scientific Corporation
Brand name: LOTUS Edge™ Aortic Valve System
Product recalled: LOTUS Edge™ Aortic Valve System
Reason of the recall: Delivery System Issues Potential inability to release the delivery system
FDA Recall date: January 11, 2021
Recall details: Boston Scie... See Morentific Corporation (NYSE: BSX) has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge™ Aortic Valve System due to complexities associated with the product delivery system. The voluntary recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant. There is no safety issue for patients who currently have an implanted LOTUS Edge valve.

Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire LOTUS product platform immediately. All related commercial, clinical, research & development and manufacturing activities will also cease.

"While we have been pleased with the benefits the LOTUS Edge valve has provided to patients, we have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform. We will instead focus our resources and efforts on our ACURATE neo2™ Aortic Valve System, Sentinel™ Cerebral Embolic Protection System and other high growth areas across our portfolio."

This decision is expected to result in estimated total pre-tax GAAP charges of approximately $225 million to $300 million due to inventory, fixed asset, intangible asset and certain other exit charges and approximately $100 million to $150 million of these charges will impact the company's adjusted results. The vast majority of these charges will be recorded during the fourth quarter of 2020. The decision is expected to be accretive to GAAP and adjusted earnings per share in 2021 by approximately one to two cents and neutral thereafter. Conference Call and Webcast Information Boston Scientific will be hosting a conference call for investors on November 17, 2020 at 8:00 a.m. EST to discuss the announcement. To participate in the conference call, please dial (833) 685-0550 or (412) 317-5733. The live webcast and archived replay of this call will be available at our Investor Relations website investors.bostonscientific.com in the Events section.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

January 28, 2021 7:00 PM

“Company name: Wahl Clipper Corporation
Brand name: Wahl
Product recalled: Deluxe Heat Therapy Massagers, Model 4212
Reason of the recall: Can overheat causing smoke or spark, which may pose a fire hazard
FDA Recall date: January 28, 2021
Recall details: Wahl Clipper Corporation is voluntarily... See Morerecalling all Deluxe Heat Therapy Massagers, Model 4212. Discontinue use immediately. The connection between the massager and heat attachment can overheat causing smoke or spark, which may pose a fire hazard. The image below shows the area where smoke or sparks may appear.

If you own a Deluxe Heat Therapy Massager, call us at 800-767-9245 or email at techsupport@wahlclipper.com. We will facilitate the free return of your unit in exchange for a full refund plus an additional $10 for this inconvenience. Your safety is important to Wahl Clipper Corporation. If you have any questions concerning this voluntary product recall, please contact us.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

February 23, 2021 9:01 PM

“Company name: Medtronic
Brand name: Medtronic Valiant Navion™
Product recalled: Thoracic stent graft system
Reason of the recall: Due to endoleaks, stent fractures and stent ring enlargement
FDA Recall date: February 23, 2021
Recall details: Medtronic plc (NYSE:MDT), the global leader in medica... See Morel technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice. In accordance with its commitment to patient safety – and in consultation with independent physicians – Medtronic initiated this action in response to information recently obtained from the Valiant Evo Global Clinical Trial indicating that three patients in the Valiant Evo Global Clinical Trial were observed to have stent fractures, two of which have confirmed type IIIb endoleaks. One patient death was reported.

Following these observations, an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial. Upon further analysis of the images, seven (7) out of 87 patients were observed to have stent ring enlargement beyond the design specification. Those observations require further assessment to determine potential clinical importance.

Medtronic is currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging. “There is nothing more important than the safety and well-being of patients,” said Nina Goodheart, senior vice president and president, Structural Heart & Aortic, which is reported as part of the Cardiac Vascular Group at Medtronic. “We treat matters of product safety with the highest priority and urgency. Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies.”

Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with regulatory authorities on this global voluntary recall.

Patient Management Recommendations: Patients with a Medtronic Valiant Navion thoracic stent graft system should consult their physician with any questions. As part of the voluntary recall of unused product, physicians were sent written communication from Medtronic directing them to immediately cease use of the Medtronic Valiant Navion thoracic stent graft system and instructions for returning unused product to Medtronic. Medtronic advises physicians to retrospectively review all available images of patients treated with Valiant Navion thoracic stent graft system with specific attention to stent fractures and type IIIb endoleaks and contact Medtronic if any imaging findings are observed.

Medtronic urges physicians to follow best clinical practices and evaluate patients with at least annual follow-up according to the imaging recommendations in the Medtronic Valiant Navion thoracic stent graft system Instructions for Use (IFU). As always, physicians are asked to notify Medtronic of any adverse events or product safety issues associated with use of any Medtronic product, which also should be reported to the FDA's MedWatch Adverse Event Reporting program. Outside of the U.S. adverse events or product safety issues associated with use of any Medtronic product should be reported to the appropriate competent authority.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 20, 2021 8:00 PM

“Company name: Becton, Dickinson and Company
Brand name: ChloraPrep
Product recalled: ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator
Reason of the recall: Defective applicator
FDA Recall date: April 20, 2021
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology co... See Morempany, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator. The product is used as an antiseptic for the preparation of the patient's skin prior to surgery to help reduce bacteria that potentially can cause skin infection.

The ChloraPrep™ 26 mL Applicator contains glass ampules that house the sterile ChloraPrep™ solution. In normal circumstances, the product is activated by squeezing the wing on the applicator to break the ampule, which releases the solution to the sponge head for application to the patient’s skin. In certain lots, the applicator end cap was improperly secured due to a manufacturing error.

This can result in broken glass and solution dropping out of the applicator once activated. In some cases, the glass ampules can drop out before activation and shatter if striking a hard surface, resulting in solution and glass fragments scattering in the procedure area and potentially causing injury to patients and health care professionals.
These products were distributed in the United States and Puerto Rico.

BD Risk Assessment: Immediate health consequences could be lacerations to patient and/or user of the device.  It is possible that these could range from superficial to deep lacerations.  While BD has no current reports of severe injury, it is possible that lacerations could cause damage to structures such as nerves or tendons, however, this is considered unlikely.

Long-term health consequences could include superficial or deep lacerations that could lead to infection and scarring. “Flying” glass shards could potentially cause injury to the patient or user, including eye injuries. Splashing ChloraPrep™ solution could contact the eyes of the user or patient. If tissues or organs other than the skin and subcutaneous tissues are damaged, permanent impairment could occur. While blood loss could accompany these injuries, it would be readily controllable with simple standard measures.

To date, BD has received 56 complaints with only one laceration injury reported with respect to this issue. As part of the voluntary recall to the user level, the company is notifying customers and distributors affected by the recall. BD’s Customer Recall Notification provides instructions to customers and distributors for disposal and replacement of the impacted ChloraPrep™ 26 mL Applicator (see list of affected lot numbers in the link below).

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product should be addressed to BD Customer Support at 1-844-8BD- LIFE (1-844-823-5433); When calling Monday- Friday between the hours of 9 a.m. to 6 p.m. ET, say “Recall” when prompted. For additional information, customers can visit www.bd-chloraprep-action.comExternal Link Disclaimer. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

The U.S. Food and Drug Administration (FDA) has been notified of this recall.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, INVESTMENTS BY DESIGN LLC, 3248 E Jump Off Rd Frnt, VALLEY, WA, 99181, USA

INVESTMENTS BY DESIGN LLC, 3248 E Jump Off Rd Frnt, VALLEY, WA, 99181, USA

May 9, 2021 12:00 PM

“Employer not wearing a mask or 6ft social distance rule after having covid.


Source: Osha.gov | Receipt Date: 2021-03-10 See Less
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April 30, 2021 6:01 PM

“Company name: Acella Pharmaceuticals, LLC
Brand name: Acella
Product recalled: NP Thyroid (Thyroid Tablets, USP)
Reason of the recall: Sub potency
FDA Recall date: April 30, 2021
Recall details: Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 belo... See Morew of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.

There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations, or cardiac arrhythmia.

To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count and 7-count bottles. See product images below. To best identify the product, the NDC’s, Product Description, Lot Numbers, and Expiration Dates are listed on the link below.

These lots were distributed nationwide in the United States to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Acella is proactively notifying its consignees to discontinue distribution of the above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. 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.

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

May 6, 2021 12:47 AM

“This was all after waiting the 20 minutes before leaving within 5 minutes after getting in my car I felt a burning in my right foot that within 20 minutes was burning both feet and legs all the way. Burning in my body from the waste down for 4 hours then severe rash all over my body except my face. See Less
Reported By SafelyHQ.com User

April 29, 2021 5:31 PM

“I ordered a "Battery-Powered Wood Cutter x 1". The picture of my order was very similar to the one next to this report I am making. They sent me an email back telling my they had two options on the page and I chose to pay for some chain looking thing that looks like you can kill someone with it. And... See Morethey refuse to give me my money back. I have the order, email correspondence and photos of the product I ordered. They advertise in very large photos one thing and then have a very small photo in the corner of something else. You had no idea was even there. Until you don't get what you ordered, but in stead you get the tiny thing in the corner. I can supply all this to you if you can stop these thieves from continuing there false business practices. See Less
Reported By SafelyHQ.com User

April 19, 2021 9:01 PM

“Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a... See Morenationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be found using the following link: Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA Consumers who have: Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or timestamp 6 should stop the distribution and use of these and return them to Tenacore LLC.
Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between July 2020 and Feb 2020, should be inspected per the instructions described below to ensure that your device is not impacted. If it is, please return your device to Tenacore LLC.
Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July 2020 through Feb 2021. The following products have been recalled:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User