Date Issued: August 20, 2021 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA is aware of allegations…
Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers
August 18, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers, health care facility risk managers, and procurement staff to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc., due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). Products manufactured by Eco-Med are…
Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N- Nitroso Varenicline Content
Summary Company Announcement Date: August 16, 2021 FDA Publish Date: August 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above acceptable daily intake level Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Smoking cessation treatment Company Announcement Pfizer is voluntarily recalling an additional four lots of…
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL) Product Codes: LWP Model Numbers: J174, J177,…
Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The recall described in this notice is the same one that was announced in the Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers…
Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May Improperly Configure Drug and Fluid Delivery
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Dose IQ Safety Software (used with Spectrum IQ Infusion System) Product Code: 35723V091 Software Version: All drug libraries initially created with version 9.0.x Distribution Dates: February 1,…
Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine.
Summary Company Announcement Date: August 11, 2021 FDA Publish Date: August 11, 2021 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description undeclared sibutramine Company Name: Ebay Seller-John Nguyen Brand Name: Brand Name(s) Max Health Product Description: Product Description Hydro Pineapple Burn Company Announcement Houston, Texas, eBay Seller ID: jongu 4308 is voluntarily recalling…
SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination
Summary Company Announcement Date: August 10, 2021 FDA Publish Date: August 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to waterborne microbial contamination Company Name: SterRx, LLC Brand Name: Brand Name(s) SterRx, LLC Product Description: Product Description Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Company Announcement SterRx, LLC…
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Incorrect Transition to Safety Mode
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL) Product Codes: LWP Model Numbers: J174, J177,…
Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Recirculator 8.0 Disposable Lavage Kit Product Code: 8100 Lot Numbers: 20021361, 20202106, 20202106, 20018480, 19854186, 20019438, 20018480, 19854186, 19854185, 20202106, 20019438, 19854184, 20202106, 20018480, 20202106, 20018480, 18687686…