Device product
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Z-0149-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1599 kits
- Official record key
device-enforcement:Z-0149-2017
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: 56958 5/29/2016 56991 6/4/2016 57637 7/5/2016 57788 7/10/2016 59063 1/22/2016 59363 3/24/2015 60073 10/30/2016 60752 10/29/2015 61309 9/27/2015 62116 11/28/2015 62453 11/14/2015 62727 11/5/2015 63987 1/8/2016 64556 1/6/2016 65214 1/1/2016 65698 11/30/2015 66531 8/9/2016 66620 11/9/2015 68220 9/28/2016 68650 9/13/2016 69059 9/22/2016 69210 5/26/2016 69417 9/7/2016 69787 1/29/2017 70198 11/30/2016 70590 9/21/2016 70993 12/6/2016 71368 12/13/2016 71904 3/30/2017 72550 1/10/2017 72914 3/29/2017 73285 7/21/2017 73824 4/5/2017 74175 5/3/2017 75314 5/11/2017 75728 7/3/2017 76171 7/7/2017 76624 8/4/2017 77162 8/10/2017 77576 10/8/2017 77742 10/2/2017 78128 9/30/2017 78139 9/22/2017 79481 1/23/2018
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.