Device product
Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
Z-0231-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 852 kits
- Official record key
device-enforcement:Z-0231-2017
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 58579 8/20/2013 62097 12/4/2013 61593 12/15/2013 59838 12/30/2013 64762 12/31/2013 60645 1/13/2014 59179 1/14/2014 67196 1/31/2014 65990 2/28/2014 63190 9/15/2014 62540 9/20/2014 67875 9/28/2014 65484 9/30/2014 69395 5/2/2016 56674 5/29/2016 71054 6/3/2016 57460 6/14/2016 68944 6/20/2016 70475 8/10/2016
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.