Device product
Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
Z-0190-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 282 kits
- Official record key
device-enforcement:Z-0190-2017
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: 59208 11/3/2015 66913 11/9/2015 64949 1/1/2016 63581 1/4/2016 56990 6/19/2016 58800 8/22/2016 68611 9/11/2016 69745 9/17/2016 73553 1/27/2017 70679 3/22/2017 73768 4/11/2017 74539 6/19/2017 75798 9/19/2017 79480 1/2/2018 80615 2/23/2018
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.