Device product
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
Z-0208-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 765 kits
- Official record key
device-enforcement:Z-0208-2017
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: 62455 8/19/2013 61070 9/10/2013 58150 1/30/2014 59474 1/31/2014 63203 9/11/2014 64165 9/14/2014 65059 9/27/2014 67591 9/29/2014 68544 5/7/2015 68386 5/24/2015 68720 9/14/2015 70550 10/8/2015 69342 10/17/2015 74095 12/2/2015 73780 12/23/2015 76033 2/22/2016 76082 2/22/2016 72977 2/25/2016 76032 2/27/2016 56835 5/29/2016
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.