FDA: Class I recall of DeRoyal surgical procedure packs
Editor's Note The Food and Drug Administration (FDA), on June 25, identified the recall of DeRoyal Industries’ surgical procedure packs as Class I, the most serious. The recall was initiated because the packs contain 1% lidocaine that had been mislabeled as 0.5% bupivacaine. The procedure packs are used for cardiac…
FDA: Class I recall of Boston Scientific’s VICI, VICI RDS Venous Stent systems
Editor's Note The Food and Drug Administration (FDA), on May 21, identified the recall by Boston Scientific Corporation of its VICI Venous Stent and VICI RDS Venous Stent systems as Class I, the most serious. The recall was initiated because of reports that the stents may migrate or move from…
FDA: BD recalls certain lots of ChloraPrep
Editor's Note The Food & Drug Administration announced on April 20 that Becton, Dickinson and Company (BD) was recalling certain lots of its ChloraPrep Hi-Lite Orange 26 mL Applicator. ChloraPrep is used as an antiseptic to prepare a patient’s skin before surgery. The recall was initiated because the Applicator, which…
Hospira recalls one lot each of 0.5% Bupivacaine and 1% Lidocaine because of mislabeling
Editor's Note Hospira Inc, a Pfizer company, announced May 4 that it is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCL Injection, USP 30 mL because of mislabeling. A portion of each lot was incorrectly labeled as the other product.…
FDA: Class I recall of Alaris Infusion Pump Module 8100
Editor's Note The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious. The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to…
FDA: Class I recall of Cordis Precise PRO Rx US Carotid System
Editor's Note The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious. The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the…
FDA: Class I recall of Medtronic’s Extracorporeal Blood Pumping Console
Editor's Note The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass. The recall was initiated…
FDA issues Class I recall of certain Medtronic ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…
FDA: Class I recall of Medtronic’s Valiant Navion Thoracic Stent Graft System
Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…
FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface
Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…
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