FDA-Device2017-03-08Class II

Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A

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
N/A
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1361-2017

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