Home / Recalls / Medical Devices
Windstone Medical Packaging, Inc. recalls ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Recalled March 8, 2017 · FDA recall Z-1294-2017 · 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
390 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
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Manufacturer(s)
Windstone Medical Packaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →