FDA-Device2017-03-08Class II

Facial Tray, part number PSS1558(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
84 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Facial Tray, part number PSS1558(A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2017

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