FDA-Device2017-03-08Class II

Upper Torso Tray, part number PSS1554(B

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
222 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Upper Torso Tray, part number PSS1554(B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1379-2017

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