FDA-Device2017-03-08Class II
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
Windstone Medical Packaging, Inc.
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.
Sold states
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.
Affected count
1787 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1378-2017Don't want to check this manually?
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