FDA: Abbott updates pacemaker firmware to address cybersecurity vulnerabilities
Editor's Note The Food and Drug Administration (FDA) announced on August 29 that it had approved a firmware update that is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to cybersecurity vulnerabilities for certain Abbott (formerly St Jude Medical) implantable cardiac pacemakers.…
FDA: Cook Medical issues recall correction, removal of certain sizes of Zenith Alpha thoracic endovascular graft
Editor's Note The Food and Drug Administration (FDA) on August 25 announced a recall correction to the instructions for use by Cook Medical (Bloomington, Indiana) for its Zenith Alpha thoracic endovascular graft. This correction removed the indication for blunt thoracic aortic injury (BTAI) because Cook has received an increase in…
FDA: Vital Rx, dba Atlantic Pharmacy and Compounding recall all lots of compounded injectable drugs
Editor's Note The Food and Drug Administration (FDA) on August 18 announced the recall by Vital Rx, dba Atlantic Pharmacy and Compounding (Pompano Beach, Florida) of all lots of compounded injectable medications because of sterility assurance. During a recent FDA inspection, investigators observed unsanitary conditions, including poor sterile production practices.…
FDA: Bella Pharmaceuticals recalls all sterile drug products
Editor's Note The Food and Drug Administration on August 18 announced the recall by Bella Pharmaceuticals (Chicago, Illinois) of all lots of unexpired sterile drug products because of a lack of sterility assurance. Affected products include all lots distributed April 17, 2017, to August 10, 2017, nationwide. Products are packaged in…
FDA: Class I recall of Zenith Alpha Thoracic Endovascular Graft by Cook Medical
Editor's Note The Food and Drug Administration (FDA) on August 16 classified the recall by Cook Medical Inc (Bloomington, Indiana) of its Zenith Alpha Thoracic Endovascular Graft as Class I, the most serious. Cook Medical is aware of reported cases where the graft became blocked or closed with blood clots…
FDA: Safety Alert on liquid-filled intragastric balloon systems
Editor's Note The Food and Drug Administration (FDA) on August 10 issued a Safety Alert to update healthcare providers on five reports of unanticipated deaths that have occurred from 2016 to the present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric…
FDA: Class I recall of Datascope Corp/Maquet intra-aortic balloon pump
Editor's Note The Food and Drug Administration (FDA) on August 4 classified the recall by Datascope Corp/Maquet (Mahwah, New Jersey) of its intra-aortic balloon pump as Class I, the most serious. The recall was issued because of the risk of a valve failure, which prevents the balloon from inflating and…
FDA: Safety Alert for triamicinolone, moxifloxacin intravitreal injection by Guardian Pharmacy Services
Editor's Note The Food and Drug Administration on July 28 issued a Safety Alert for compounded triamicinolone and moxifloxacin for intravitreal injection by Guardian Pharmacy Services (Dallas, Texas). [The Guardian Pharmacy Services in Dallas is not affiliated with the national long-term care Guardian Pharmacy Services, LLC headquartered in Atlanta.] The…
FDA: ICU Medical recalls one lot of 0.9% sodium chloride injection, USP 1,000 mL
Editor's note The Food and Drug Administration (FDA) on July 31 announced the recall by ICU Medical, Inc (San Clemente, California) of one lot of 0.9% sodium chloride injection, USP 1,000 mL. The recall was issued because of a confirmed customer complaint of particulate matter identified as stainless steel in…
FDA: Oscor recalls Atar extension cables
Editor's Note The Food and Drug Administration (FDA) on July 6 announced the recall by Oscor Inc (Palm Harbor, Florida) of its Atar extension cables. The recall was initiated because, during use, some of the cables were separating from the connectors at the proximal end. The Atar cable is an…
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