Device product
Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
Z-0232-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 175 kits
- Official record key
device-enforcement:Z-0232-2017
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 59849 9/7/2015 65027 10/19/2015 62205 11/5/2015 57300 7/1/2016 77646 7/30/2016 66323 8/27/2016 73020 1/29/2017 70214 1/30/2017 75780 7/8/2017
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.