Device product
Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
Z-0168-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1584 kits
- Official record key
device-enforcement:Z-0168-2017
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 57411 5/13/2015 58475 5/14/2015 57820 5/17/2015 60799 8/3/2015 62975 11/14/2015 63103 11/14/2015 62235 11/15/2015 62675 11/25/2015 65935 11/27/2015 60995 11/29/2015 63104 12/14/2015 64487 1/5/2016 63521 1/29/2016 67570 4/30/2016 68694 7/11/2016 69235 7/14/2016 68935 7/18/2016 67788 7/30/2016 70949 9/19/2016 76072 11/2/2016 80515 11/2/2016 74746 11/9/2016 76638 11/25/2016 73892 11/26/2016 75428 11/28/2016 79295 11/30/2016 71620 12/12/2016 70720 1/4/2017 75219 5/31/2017 77663 6/19/2017 78672 8/22/2017
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.