Device product
Plastic Kit, part number CMP1084(C
Z-1360-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 580 kits
- Official record key
device-enforcement:Z-1360-2017
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 86626, 9/3/2017 87202, 9/16/2017 87481, 9/9/2017 87924, 9/17/2017 88217, 10/31/2017 88819, 10/27/2017 89271, 10/11/2017 89539, 12/7/2017 95831, 1/9/2018 96460, 4/12/2018 98055, 6/30/2018 98962, 6/22/2018 99088, 9/15/2018
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.