Device product
Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
Z-0241-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 352 kits
- Official record key
device-enforcement:Z-0241-2017
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: 59453 8/2/2013 58726 8/21/2013 62658 12/11/2013 63489 12/17/2013 61162 12/21/2013 60183 12/29/2013 65535 1/31/2014 66430 1/31/2014 66807 1/31/2014 61804 2/7/2014 67876 9/5/2014 64144 9/7/2014 64457 9/30/2014 64909 9/30/2014 69781 5/2/2016 68945 5/10/2016 71058 6/4/2016 57425 6/28/2016
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.