FDA-Device2017-03-08Class II

Stem Pack, part number AMS5166

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
16 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Stem Pack, part number AMS5166

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2017

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