FDA-Device2017-03-08Class II
Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
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
170
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2017Don't want to check this manually?
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