Device product
Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room
Z-0281-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 546 kits
- Official record key
device-enforcement:Z-0281-2017
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: 58440 12/26/2014 57416 2/5/2015 56848 2/23/2015 59052 5/17/2015 58812 5/28/2015 63227 7/20/2015 61936 8/28/2015 59666 10/14/2015 65111 10/20/2015 64230 11/10/2015 65410 12/11/2015 66232 5/19/2016 67772 7/9/2016 57871 7/12/2016 68610 9/20/2016 78517 9/30/2016 70880 10/28/2016 71119 12/14/2016 74426 12/24/2016 73427 1/22/2017 72781 1/30/2017 73810 3/18/2017 78127 8/18/2017 79916 9/20/2017
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.