Device product
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
Z-0238-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 356 kits
- Official record key
device-enforcement:Z-0238-2017
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: 58414 8/13/2013 62931 12/9/2013 60184 12/29/2013 59455 1/9/2014 61163 1/21/2014 66804 1/31/2014 65169 2/28/2014 67878 9/11/2014 62190 9/26/2014 64342 9/30/2014 68948 5/10/2016 70180 5/16/2016 57028 5/30/2016 71059 6/4/2016 57611 7/2/2016
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.