Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for… — recall Z-0237-2017
U.S. FDA — Device Enforcement · United States · 2015-04-22 · Class II
As described by U.S. FDA — Device Enforcement: Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Reported risk: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
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