Device product
Facial Tray, part number PSS1558(A
Z-1302-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 kits
- Official record key
device-enforcement:Z-1302-2017
Official wording
Reason: 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.
Code information: Lot number and expiration date 101651, 10/15/2019 84873, 6/3/2018 87601, 8/25/2018 87884, 9/30/2018 88601, 10/9/2018 89542, 12/29/2018 95493, 1/3/2019 96353, 1/31/2019 97496, 6/29/2019
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.