Device product
Peri GYN, part number PSS2193(A
Z-1358-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 kits
- Official record key
device-enforcement:Z-1358-2017
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 86291, 9/19/2017 87829, 10/7/2017 96967, 4/21/2018 98214, 6/19/2018 99585, 9/28/2018
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.