GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall

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 Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, Giraffe OmniBed Carestation. All Giraffe Incubators and Giraffe OmniBeds Manufacturing Dates: April 2008 to September 2019 Distribution Dates: April 2000…

Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall

Recalled Product SynchroMed II pump, Model numbers 8637-20 and 8637-40 Manufacturing Dates: May 4, 2018 to April 5, 2019 Distribution Dates: May 11, 2018 to September 5, 2019 Devices Recalled in the U.S.: 7,317 Date Initiated by Firm: October 9, 2019 Device Use The Medtronic SynchroMed II implantable drug infusion pump, part of the SynchroMed…

Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products

[Posted 12/09/2019] AUDIENCE: Health Professional, Patient, Consumer, Risk Manager ISSUE: FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. FDA is carefully assessing this situation along with our federal…

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing

Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 26, 2019 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential leakage at joint between blood filter and tubing Company Name: B. Braun Medical, Inc. Brand Name: Brand Name(s) Product Description: Product Description Blood Administration Kits Company Announcement B. Braun Medical Inc….

Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: November 19, 2019 FDA Publish Date: November 19, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Company Name: Precision Dose Inc. Brand Name: Brand Name(s) PrecisionDose Product Description: Product Description Ranitidine Oral Solution, USP 150 mg/10 mL Company…

Update On Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

November 19, 2019 The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. In our previous letter to health care providers, the FDA informed providers about reports of Maquet/Datascope IABP devices shutting…

Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

November 1, 2018 Dear Cardiologists, Cardiothoracic Surgeons, Anesthesiologists, Nurses, Critical Care Specialists and Biomedical Engineers: We are writing to inform you that the FDA is evaluating recent reports of Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. These devices are used on critically-ill patients in health care facilities, including…

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 15, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Company Name: GSMS, Inc. Brand Name: Brand Name(s) GSMS Incorporated Product Description: Product Description Ranitidine HCl 150mg and 300mg Capsules Company Announcement…