FDA-Device2017-03-08Class II

Arthroscopy Pack, part number AMS6559

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
60 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Arthroscopy Pack, part number AMS6559

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2017

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