Device product
Transvaginal Pack, part number CMP1767
Z-1376-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 650 kits
- Official record key
device-enforcement:Z-1376-2017
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 85689, 7/24/2018 85859, 8/1/2018 86125, 11/14/2018 89073, 11/25/2018 89074, 11/22/2018 89211, 12/11/2018 89212, 12/3/2018 89273, 6/15/2019 97315, 5/6/2019 97489, 6/27/2019 98343, 6/10/2019 98344, 9/9/2019
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.