Device product
Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
Z-0263-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 204 kits
- Official record key
device-enforcement:Z-0263-2017
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 Number/ Expiration Date: 58987 3/10/2014 65124 6/13/2014 63594 6/30/2014 65383 7/3/2014 67936 9/16/2014 68657 9/20/2014 67280 9/27/2014 76180 6/10/2016 57602 6/18/2016 78529 7/30/2016 59242 8/27/2016 80645 11/19/2016
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.