Windstone Medical Packaging, Inc. recalls Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthr…
- Recall date
- January 11, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1261-2017
- 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
Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
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