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…
Proactive steps paramount for greater surgical stapler safety
Internal surgical staplers made headline news in 2019. Reports discussed the little-known US Food and Drug Administration database housing tens of thousands of stapler-related problem reports and covered the agency’s recent proposal to reclassify staplers as Class II devices, instead of the more lightly regulated Class I. ECRI Institute named…
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…
FDA: Class I recall of Vyaire Medical enFlow fluid warming disposable cartridge
Editor's Note The Food & Drug Administration (FDA) on August 21 identified Medline Industries’ recall of Centurion Medical Products’ Primary Warmer Pack containing the Vyaire Medical enFlow fluid warming system disposable cartridge as Class I, the most serious. The recall was initiated because the cartridge may elute aluminum into infused…
FDA: Class I recall of Edwards Lifesciences SAPIEN 3 Ultra Delivery System
Editor's Note The Food and Drug Administration on August 22 identified the recall by Edwards Lifesciences of all lots of its SAPIEN 3 Ultra Delivery System as Class I, the most serious. The delivery system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. The recall was initiated…
FDA: Class I recall of Volumat MC Agilia Infusion System, Vigilant Drug Library
Editor's Note The Food & Drug Administration on August 12 identified the recall by Fresenius Kabi (Bad Homburg, Germany) of its Volumat MC Agilia Infusion System and Vigilant Drug Library as Class I, the most serious. The recall was initiated because of a “Low Priority,” “Keep Vein Open,” “End of…
FDA: Class I recall of Teleflex/Sheridan Endotracheal Tubes
Editor's Note The Food & Drug Administration (FDA) on August 2 identified the recall by Centurion Medical Products of its Airway Kit containing Teleflex/Sheridan Endotracheal Tubes as Class I, the most serious. The recall was initiated because of the potential for the tube connector to dislodge from the endotracheal tube,…
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