FDA-Device2017-03-08Class II

Foot Pack, part number AMS3637

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
40 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Foot Pack, part number AMS3637

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2017

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