Device product
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
Z-0235-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1200 kits
- Official record key
device-enforcement:Z-0235-2017
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: 59180 8/13/2013 58144 11/7/2013 63191 12/3/2013 62098 12/6/2013 61064 12/13/2013 61592 12/16/2013 63809 12/17/2013 62398 12/19/2013 60127 12/20/2013 59454 1/25/2014 66802 1/31/2014 67030 1/31/2014 59839 2/16/2014 61296 2/21/2014 65291 2/28/2014 68567 9/5/2014 62930 9/20/2014 67877 9/21/2014 64458 9/30/2014 71056 10/11/2015 68946 10/26/2015 69206 5/10/2016 69631 5/23/2016 70482 5/29/2016 71057 6/4/2016 57292 6/11/2016 57780 6/23/2016
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.