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Windstone Medical Packaging, Inc. recalls Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797
Recalled March 8, 2017 · FDA recall Z-1319-2017 · Windstone Medical Packaging
Hazard
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. · FDA Class II
Units
130 kits
Sold at
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.
Description
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.
Product
Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B
Manufacturer(s)
Windstone Medical Packaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →