Device product
Minor Procedure Pack, part number AMS4799
Z-1342-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 365 kits
- Official record key
device-enforcement:Z-1342-2017
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 100253, 3/31/2018 88213, 4/30/2017 88671, 4/13/2017 88876, 4/22/2017 89097, 4/30/2017 89205, 4/15/2017 94555, 3/31/2017 94588, 3/31/2017 95305, 3/31/2017 96331, 10/26/2017 97150, 11/30/2017 98711, 11/30/2017
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.