Device product
General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room
Z-0197-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 985 kits
- Official record key
device-enforcement:Z-0197-2017
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: 60558 11/6/2014 58503 11/9/2014 58887 11/15/2014 61480 11/21/2014 61881 5/16/2015 62122 5/25/2015 72125 3/12/2016 56859 5/22/2016 57574 6/26/2016 75367 10/18/2016 78105 10/20/2016 72126 10/21/2016 73669 10/23/2016 74705 10/23/2016 72127 10/27/2016 76745 4/2/2017 75824 4/23/2017 79786 8/6/2017
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.