Device product
General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room
Z-0198-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 168 kits
- Official record key
device-enforcement:Z-0198-2017
Official wording
Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Code information: Lot Numbers/ Expiration Dates: 70328 2/3/2015 65789 2/26/2015 65574 11/9/2015 62152 11/13/2015 68748 12/27/2015 63873 1/24/2016 66910 5/30/2016 72335 7/8/2016 72751 7/25/2016 79224 9/10/2017 75804 10/9/2017 79488 1/9/2018
Distribution pattern: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Derived failure modes
-
Unknown
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.