Device product
Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
Z-0185-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 816 kits
- Official record key
device-enforcement:Z-0185-2017
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: 59843 3/1/2015 60753 8/17/2015 59894 9/6/2015 65996 11/13/2015 61600 11/28/2015 62117 12/12/2015 64160 1/3/2016 69211 5/5/2016 56959 6/8/2016 57789 7/1/2016 67355 7/5/2016 58586 8/27/2016 69588 10/8/2016 70509 1/6/2017 72551 1/10/2017 76068 7/17/2017 77502 7/17/2017 78140 9/19/2017
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.