Device product
Laminectomy Pack, part number PSS1844(B
Z-1323-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 291 kits
- Official record key
device-enforcement:Z-1323-2017
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 83287, 8/9/2017 87158, 7/10/2017 88004, 10/5/2017 88548, 10/14/2017 89055, 11/16/2017 89903, 12/28/2017 95142, 2/12/2018 95314, 2/9/2018 95839, 2/12/2018 96468, 3/26/2018 96630, 4/11/2018 96820, 6/12/2018 98748, 10/20/2017 99774, 6/24/2018
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.