FDA-Device2017-03-08Class II

Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C

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
156 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2017

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