Device product
Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
Z-0150-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1243 kits
- Official record key
device-enforcement:Z-0150-2017
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: 67015 7/5/2016 67549 8/10/2016 68418 7/7/2016 68820 9/19/2016 68959 9/12/2016 69548 9/20/2016 69852 10/23/2016 70495 10/20/2016 71780 12/11/2016 71957 10/20/2016 71958 1/7/2017 72481 3/15/2017 73643 1/22/2017 73644 4/10/2017 73850 4/23/2017 74062 7/9/2017 76185 7/11/2017 76345 8/31/2017 76673 10/21/2017 77769 10/4/2017 78025 9/22/2017 78741 1/17/2018 80940 8/8/2017
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.