FDA: Class I recall of Philips Medical System’s Forte Gamma Camera System
Editor's Note The Food & Drug Administration (FDA) on November 4 identified Philips Medical System’s (Cleveland) recall of its Forte Gamma Camera System as Class I, the most serious. The recall was initiated because of the potential for the detector, which weighs 660 pounds, to become detached from the device…
FDA: Class I recall of Abbott CentriMag Circulatory Support System
Editor's Note The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious. The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop,…
FDA clears Heartvista’s AI-assisted cardiac MRI tool
Editor's Note Heartvista (Los Altos, California) has obtained clearance from the Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted One Click autonomous MRI acquisition software for cardiac ischemia exams, the October 30 BioWorld MedTech reports. Integrated with existing MRI scanners, the software uses AI to guide image acquisition,…
FDA: ICU Medical recalls Lactated Ringer’s Injection, 0.9% Sodium Chloride Injection
Editor's Note The Food & Drug Administration on October 30 announced the nationwide recall by ICU Medical (San Clemente, California) of one lot of Lactated Ringer’s Injection, USP, and one lot of 0.9% Sodium Chloride Injection because of the presence of particulate matter. The affected lot numbers are: Lactated Ringer’s…
FDA: Class I recall of Ethicon Echelon Flex Endopath staplers
Editor's Note The Food & Drug Administration on October 30 identified the recall by Ethicon of its Echelon Flex Endopath staplers as Class I, the most serious. The recall was initiated because of failure of the staplers to completely form staples. As of October 3, 2019, seven serious injuries and one…
FDA of device shortages because of sterilization facility closures
Editor's Note The Food and Drug Administration (FDA) on October 25 released a statement warning of possible device shortages because of interruptions in ethylene oxide (EO) sterilization services due to facility closures in Illinois and Georgia. In the statement, the acting FDA Commissioner, Ned Sharpless, noted that “at this time…
FDA: Class I recall of Medtronic’s 6 French Sherpa NX Active Guide Catheters
Editor's Note The Food & Drug Administration (FDA) on October 8 announced the recall by Medtronic of all models of its 6 French Sherpa NX Active Guide Catheters. Medtronic is recalling the catheters because of the risk of the outer material separating from the device, resulting in detached fragments that…
FDA: Class I recall of Allergan Natrelle Biocell textured breast implants
Editor's Note The Food & Drug Administration (FDA) on September 12 designated the recall by Allergan of its Natrelle Biocell textured breast implants as Class I, the most serious. The recall was initiated because of a six times higher rate of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer…
FDA: Metrix Company recalls certain lots of empty flexible IV bags
Editor's Note The Food & Drug Administration on September 10 posted the recall by the Metrix Company of Dubuque, Iowa, of specific lots of its empty IV flexible containers (bags) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names. The recall was initiated because of the potential…
FDA: Hospira recalls one lot of Bacteriostatic Water for Injection
Editor's Note The Food & Drug Administration on September 6 posted Hospira, Inc’s recall of one lot of Bacteriostatic Water for Injection, USP, 30 mL, multi-dose vials, lot W20308. The recall was initiated because of the potential for a lack of sterility assurance. To date, Hospira has not received any…
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