FDAApril 22, 2015device

Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

windstone medical packagingwindstonewindstone medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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