Medical device recalls Moderate risk

Windstone Medical Packaging, Inc. recalls Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A

Recall date
January 11, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1332-2017
FDA classification
Class II
Brand / firm
Windstone Medical Packaging, Inc.
Sold / distributed
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

Why it was recalled

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A

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