Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case! Your contact information is not shown on the website.
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Use camera
Select from library
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

If your report is poison related call 1-800-222-1222 for a free consultation with a live medical poisoning expert

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Medical Devices

Updated: October 19, 2021 2:00 PM
Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary... See More recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. The needles were recalled due to complaints of rust on the products. Use of affected products could result in increased procedural time and inflammatory reactions, including systemic reactions which may lead to permanent impairment or death.

The U.S. Food and Drug Administration (FDA) has not yet classified the recall. Products affected by this recall are:
- Transseptal Needle, INTENDED USE: Intended for transseptal left heart access in both diagnostic and interventional procedures, RPN: TSNC-18-71.0 GPN: G02364 and RPN: TSNC-19-56.0 GPN: G02365, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021
- Transseptal Needle with Catheter, INTENDED USE: Intended to facilitate transseptal entry into the left atrium, RPN: TSN-17-75.0-ENDRYS, GPN: G19261, all lot numbers, RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS: October 02, 2016 through July 22, 2021

Transseptal Needles, including Transseptal Needles with Catheters, were found to have rust internally, externally, or both. To date, Cook Medical has received no reports of injury or illness related to this recall. Cook has received four complaints where the presence of rust was identified prior to patient contact. However, please be advised that the presence of rust may go undetected by the user. The FDA and other regulatory agencies around the world have been notified of this action.

Potential adverse events: If an affected product is used, potential negative outcomes include increased procedural time (to obtain a replacement device) and inflammatory reactions ranging from local or self-limited reactions to systemic reactions requiring medical intervention. Systemic reactions could potentially lead to permanent impairment or death.

Check the full recall details on fda.gov

Source: FDA
See Less
97


Company name: Meridian Bioscience, Inc.
Brand name: Meridian Bioscience, Inc.
Product recalled: LeadCare® Test Kits
Reason of the recall: LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples
FDA Recall date: September 02, 2021
Recall details: Meridian Bioscience, Inc. (NASDAQ: VIVO),... See More a provider of diagnostic testing solutions and life science raw materials, today announced its wholly owned subsidiary, Magellan Diagnostics, Inc. (“Magellan”), expanded the Class I recall of its LeadCare® II Blood Lead Test Kits, LeadCare Plus® Blood Lead Test Kits, and LeadCare Ultra® Blood Lead Test Kits (the “LeadCare Test Kits”) for the detection of lead in whole blood.

Magellan provides two controls in the test kits which are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range.  Results of the control tests within the acceptable range indicate that the system is operating properly before testing patient samples. 

In May 2021, Magellan initiated this voluntary recall after identifying an ongoing issue with testing of the controls included in the LeadCare Test Kits.  Magellan continues to investigate this issue and has conducted extensive testing to evaluate potential root causes.  

Scope of Recall: Magellan received reports that control tests of either the “Low-Control” (e.g., the “Level 1” control at approximately 9 g/dL ± 3g/dL) and/or the “High-Control” (e.g., the “Level 2” control at approximately 28 g/dL ± 4g/dL) generated a “low” result (i.e., “Control Out of Range-Low” [“COOR-L”]). 

Magellan initiated the recall because the impacted LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples. As part of the recall to the user level, Magellan is notifying customers and distributors affected by the recall.  Magellan's customer recall notification provides instructions for the return and replacement of the impacted LeadCare Test Kits (see list of affected lot numbers in the link below).

Magellan recommends the following:

- Customers should discontinue use of all LeadCare Test Kits lots identified as part of the recall and quarantine remaining inventory.
- Distributors should stop distribution of all LeadCare Test Kits lots identified as part of the recall, review current inventory and quarantine any remaining stock.
- Health Care Providers should evaluate patient test results that were generated with all recalled lots.
- Suspect results should be confirmed with an alternative lead testing option, such as those using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) at a high complexity, CLIA-certified, reference laboratory.
- See CDC’s recommended actions based on blood lead level
- Promptly complete and return the Customer Notification Form in the Urgent Medical Device Recall letter to FAX to (978) 600-1480. Complete this form even if you have no remaining inventory.
- After the form has been submitted, contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan and receive replacement product when available.

Product distribution has been paused until further notice and replacement product is currently unavailable. Magellan continues to investigate the root cause of the COOR-LO failure mode and is working diligently to find a solution to resume shipments/replacements as quickly as possible. If you have questions about this recall, please contact Magellan’s LeadCare® Product Support Team at 1-800-275-0102

Check the full recall details on fda.gov

Source: FDA
See Less
97


Company name: Baxter International Inc.
Brand name: Spectrum IQ
Product recalled: Infusion Pumps
Reason of the recall: Multiple Connectivity Errors
FDA Recall date: August 24, 2021
Recall details: Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps... See More to reinforce important safety information when customers implement changes to their network configuration and server systems. Baxter previously communicated this information to customers via an Urgent Medical Device Correction notification on June 4, 2021 and a follow-up communication with updated information on August 2, 2021.

Two Spectrum IQ infusion pump customers notified Baxter of system errors occurring in multiple pumps within their fleets following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in multiple pump connectivity errors, placing stress on the pump’s processor. When this occurs, pumps initiate a “watchdog” system error alarm to notify the user of the issue, causing the pump to enter a fail-safe mode which stops all pump processes, including delivery of fluid to the patient. For both customers, the watchdog system errors were resolved by restoring network and server system performance to expected levels.

- Spectrum IQ Infusion System with Dose IQ Safety Software. Product Code: 3570009. Serial Numbers: All

To date, there have been no reports of adverse events or patient injury associated with this issue. However, depending on several factors, such as the length of delay, medication being infused, the volume and rate of the infusion, patient status, and comorbidities, the patient may experience serious adverse health consequences or death. Baxter is developing a software upgrade for all Spectrum IQ infusion pumps that will assist how the pump responds to unstable network and server systems by reducing the stress on the pump’s memory and processing functions if this occurs.

The updated software is currently expected to be available early in the fourth quarter of 2021, and Baxter will work with customers to schedule the software upgrades. To reduce the likelihood of encountering this issue, Baxter is asking customers to contact Baxter Technical Assistance at 800-356-3454 in advance of making changes to their network or server infrastructure supporting the pumps or the Baxter Gateway. Changes requiring prior notice can be found in the Urgent Medical Device Correction communication and in Baxter’s Gateway Server Installation Handoff document, which customers receive upon installation. Additionally, Baxter recommends that customers ensure backup devices are readily available when infusing critical medications.

Customers with additional questions can contact their Baxter sales representative or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday between 6 a.m. and 6 p.m. Central Time. Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
97


Company name: Cardinal Health
Brand name: Monoject
Product recalled: Flush Prefilled Saline Syringes
Reason of the recall: Products have been found to reintroduce air into the syringe after the air has been expelled
FDA Recall date: August 20, 2021
Recall details: On August 4, 2021, Cardinal Health... See More (NYSE: CAH) initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death.

Customers who have affected product(s) should immediately review their inventory and quarantine and return all affected product. The recall applies to all lots of the products manufactured from July 2019 to June 2021 distributed between July 2019 and July 2021. The following SKUs have been recalled:

- 12mL Syringe, 10 mL Saline Fill. SKUs: 8881570121
- 12mL Syringe, 3 mL Saline Fill. SKUs: 8881570123
- 12mL Syringe, 5 mL Saline Fill. SKUs: 8881570125

Our Monoject™ 3mL syringe, 2.5mL Saline Fill is not affected by this recall. This item, SKU 8881570300, will be available for sale until inventory is depleted.

MonojectTM Flush Prefilled Saline Syringes can be identified by the barrel of the syringe, the case and the box as shown in the pictures below.

The company has received 37 reports of the plunger pulling back. No injuries have been reported to date. Cardinal Health voluntarily recalled MonojectTM Flush Prefilled Saline Syringes after learning that there is potential for the syringe’s plunger to draw back and reintroduce air back into the syringe. Cardinal Health has notified the U.S. Food and Drug Administration of this action.

Cardinal Health notified its distributors and customers by overnight delivery of a notification packet on August 5, 2021 and is arranging for return of all recalled products.

Given the limited number of alternative prefilled saline syringe options, combined with ongoing supply, transportation and labor challenges, we anticipate that this recall may contribute to a market disruption of prefilled saline syringes.

Cardinal Health distributes this product nationwide.

Check the full recall details on fda.gov

Source: FDA
See Less
97


Company name: Eco-Med Pharmaceutical
Brand name: Multiple brand names
Product recalled: Ultrasound Gel
Reason of the recall: Product is contaminated with bacteria (Burkholderia cepacia complex)
FDA Recall date: August 04, 2021
Recall details: Etobicoke, Ontario (August 4, 2021) – Eco-Med Pharmaceuticals, Inc. today commenced a voluntary recall... See More of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and not indicated for sterile procedures. Eco-Med is instructing all health care facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med. Affected product lot numbers are below:

- Product: Eco Gel 200 MediChoice M500812

- Lot Numbers and Initial Distribution Date:

B029 March 26, 2021
B030 March 30, 2021
B031 April 5, 2021
B032 April 7, 2021
B040 April 26, 2021
B041 April 26, 2021
B048 May 7, 2021
B055 May 26, 2021

Additionally, Eco-Med is instructing all health care facilities to immediately stop use and quarantine all lots of the following ultrasound gels distributed under these brand names in these geographies:

EcoGel 200, by Eco-Med (Canada)
MediChoice Ultrasound Gel, by Owens & Minor (United States)
MediChoice Ultrasound Gel, by Mac Medical Supply Co Inc. (United States)
EcoGel 200, by Active Crystal Inc (Canada)
EcoGel 200, by Agencia Matamoros (Honduras)
EcoGel 200, by Cardinal Health Canada
EcoGel 200, by CMCC Supply Centre and Bookstore (Canada)
EcoGel 200 Blue, by Christie Innomed Inc. (Canada)
EcoGel 200, by Dectro International (Canada)
EcoGel 200, by Medline Canada
EcoGel 200, by Dunbar Medical (Canada)
EcoGel 200, by Eastern Medical Supply Ltd (Canada)
EcoGel 200, by Global Medical Solution (NZ) LTD (New Zealand)
EcoGel 200, by Good-link Electronics Ltd. (Hong Kong)
EcoGel 200, by Henry Schein Arcona (Canada)
EcoGel 200, by Maranda Lauzon Inc (Canada)
EcoGel 200, by Medi’s Part Ltd. (Thailand)
EcoGel 200 Blue, by MJM Distributing (Canada)
EcoGel 200, by Ortho Canada (Canada)
EcoGel 200, by So medico SDN BHD (Malaysia)
EcoGel 200 and EcoGel 200 Blue, by STAT Healthcare Corporation (Canada)
EcoGel 200 and EcoGel 200 Blue, by The Stevens Company Limited (Canada)
EcoGel 200, by Strathroy Middlesex General Hospital (Canada)
EcoGel 200, by Trimedic Supply Network Ltd. (Canada)
EcoGel 200, by Vitality Depot (Canada)
Chattanooga Conductor USA, by DJO Global (United States)
Conductor Australia, by DJO Australia
DJO Conductor, by DJO Global (United States)
Liquasonic, by Athena Medical Products Inc. (United States)
Medico, by Medico Inc. (Canada)
Medline, by Medline Industries Inc. (United States)
NDC Eco-Gel 200 Ultrasound Gel, by NDC Inc. (United States)
Omni, by Accelerated Care Plus Leasing Inc. (United States)
Red Medical Ultrasound Gel Blue, by Red Medical Supplies Ltd. (Canada)
Smart 200, by Smart Technology and Product Co., Ltd (Thailand)

Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc). The source(s) of the bacterial contamination is currently unknown. Eco-Med is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action.

The effects of the bacteria, Burkholderia stabilis, a member of the Burkholderia cepacia complex (Bcc), vary widely, ranging from no symptoms at all to serious infections. Bcc bloodstream infections may result in sepsis and in certain cases, potentially death. Use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, including bloodstream infections. Additional infections have been identified that may also be associated with the use of this ultrasound gel and investigation is ongoing. Potential routes of transmission leading to bloodstream infections associated with a contaminated nonsterile gel may have included the use of the gel for visualization prior to, in preparation for, or during an invasive procedure or application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance.

Check the full recall details on fda.gov

Source: FDA
See Less
97


Company name: Becton, Dickinson and Company
Brand name: BD
Product recalled: Alaris System
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: August 02, 2021
Recall details: FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswire/ BD (Becton, Dickinson and Company) (NYSE: BDX), a... See More leading global medical technology company, today announced the company will begin remediation for the February 4, 2020 BD Alaris™ System 1 recall through a new version of software.

The February 4, 2020 voluntary recall action notified customers of the following areas where the infusion pump may not operate as expected:

- 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 Custom Concentrations Programming

Under U.S. Food and Drug Administration (FDA) guidance, BD will release Alaris™ System software version 12.1.2 and associated ancillary software to remediate the affected software. Effective today, customers can begin scheduling remediation by contacting the BD Recall Support Center at 1-888-562-6018.

The new software, which will be available at no cost to customers, is expected to remediate the issues identified in the February 4, 2020 recall notice and provide programming, operational, and cybersecurity updates to affected devices; however, this software update has not been reviewed or cleared by the FDA. In April 2021, BD announced that the company has submitted a 510(k) submission to the FDA for the BD Alaris™ System, which is intended to bring the regulatory clearance up to date.

This submission covers all modifications to the BD Alaris™ System since its last 510(k) clearance, including updated hardware features as well as software version 12.1.2.

"Frontline clinicians continue to rely on the BD Alaris™ System to deliver medications, fluids and blood products to support the care of their patients," said Michael Garrison, worldwide president of Medication Management Solutions for BD. "This remediation is a positive step forward for our customers while the FDA reviews our 510(k) submission." The BD Alaris™ System allows clinicians to deliver medications, fluids and blood products through a single integrated platform that includes large volume pumps, syringe pumps and patient-controlled analgesia (PCA) modules for adult, pediatric and neonatal patients.

Check the full recall details on fda.gov

Source: FDA
See Less
97


Company name: Smiths Medical
Brand name: Jelco
Product recalled: Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Reason of the recall: Skewed odd number line graduation markings on syringe barrels.
FDA Recall date: June 17, 2021
Recall details: Company Announcement Smiths Medical has become aware of specific models and... See More lots of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. Markings skewed approximately 20 degrees upward have been identified. Affected Models and Lot Numbers:

- Model Number: 4428-1
- Name: Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 28Gx1/2” 1CC
- Lot Number: 4046543 and 4062235

- Model Number: 4429-1
- Name: Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 29Gx1/2” 1CC
- Lot Number: 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 4062242

Please reference the attachment for an illustration of the skewed graduation marking on the syringe barrel.

As a result of this issue, there is potential for administration of an incorrect dose of insulin, which could result in hyperglycemia (which may lead to ketoacidosis) or hypoglycemia (which may lead to seizures). This may result in serious harm or death.

Home Healthcare Environments: the lot number can be found on the packaging for the syringe. Do not use any syringes with the affected lot numbers. The patient or caretaker should contact the pharmacy, home healthcare provider or medical facility that provided the syringe to arrange for return of the syringe and replacement.

Check the full recall details on fda.gov

Source: FDA
See Less
97


Company name: Philips
Brand name: Philips
Product recalled: Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices
Reason of the recall: Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices
FDA Recall date:... See More June 15, 2021
Recall details:
- Philips is initiating a voluntary recall notification* to ensure patient safety in consultation with regulatory agencies
- Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices
- Philips aims to address all affected devices within the scope of this correction as expeditiously as possible.

Amsterdam, the Netherlands – Following the company update on April 26, 2021, Royal Philips(NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.

To date, Philips has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation.

Therefore, Philips has decided to voluntarily issue a recall notification* to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.

Recall notification* advise for patients and customers. Based on the latest analysis of potential health risks and out of an abundance of caution, the recall notification* advises patients and customers to take the following actions:

- For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.*

- For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.*

Possible health risks: The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. To date, there have been no reports of death as a result of these issues.

Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.

The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions.

*This is a recall notification for the US only, and a field safety notice for the rest of the world
**Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication.

Check the full recall details on fda.gov

Source: FDA
See Less
97


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 company, is voluntarily recalling specified lots... See More 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
97


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... See More 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
See Less
98