The FDA announced on February 12, 2020 a Class I recall of 322,005 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) (all lots before October 2019) and Model 670G (MMT-1780) (all lots before August 2019). The distribution dates for Model… Read More
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9.1M Surgical Gowns Recalled
On January 21, 2020, “Cardinal Health informed customers of a voluntary recall for the surgical gowns produced by a contract manufacturer after discovering that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required… Read More
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Alaris™ Pump Modules Model 8100 Recalls
In a recall notification sent on April 15, 2019, Becton, Dickinson and Company (“BD”) informed clinicians that the bezel assemblies in certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 were manufactured with a specific type… Read More
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Kaiser Health News Reports On FDA’s “Hidden” Database Of Malfunctions Of Medical Devices
Kaiser Health News reported on June 27, 2019 that its investigation found that “[medical] device manufacturers, for the past two decades, had been sending reports of injuries or malfunctions to the little-known database [alternative summary reporting database], bypassing the public… Read More
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FDA Issues Safety Communication Regarding The Stryker Wingspan Stent System
The FDA issued a Safety Communcation on April 25, 2019 entitled, “Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication” in which the FDA warned: “a… Read More
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FDA Orders Manufacturers Of Surgical Mesh For Pelvic Organ Prolapse To Cease Sales And Distribution
On April 16, 2019, the U.S. Food and Drug Administration (FDA) ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to immediately stop selling and distributing their products in the… Read More
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When Will The FDA Investigate The Metal In Filshie Clips?
The FDA issued a statemnet on March 15, 2019 entitled “Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address… Read More
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Stryker Defibrillator Recall
On February 1, 2019, Stryker issued an “URGENT MEDICAL DEVICE SAFETY NOTICE & CORRECTION ACTION REQUIRED” regarding its LIFEPAK® 15 Monitor/Defibrillator, stating that “Stryker is conducting a voluntary Field Action for specific LIFEPAK 15 Monitor/Defibrillator devices that may lock-up after… Read More
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Mycobacteria Chimaera Infections Associated With Heater-Cooler Unit Use During Cardiopulmonary Bypass Surgery
In December 2016, a hospital in Los Angeles County, California reported two Mycobacterium avium complex infections, later identified as Mycobacterium chimaera, in patients with a recent history (
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Olympus Medical Systems Corporation Pleads Guilty To Failing To Report Infections Associated With Its Duodenoscopes
The U.S. Department of Justice announced on December 10, 2018 that Olympus Medical Systems Corporation (“Olympus”), and a former senior executive in Japan, have pled guilty to failing to file required adverse event reports involving infections connected to its duodenoscopes,… Read More
