Device product
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
Z-0159-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 268 kits
- Official record key
device-enforcement:Z-0159-2017
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: 58207 8/31/2013 61591 1/2/2014 59228 1/19/2014 66522 1/31/2014 61763 3/5/2014 62929 9/10/2014 67485 9/19/2014 67664 9/21/2014 63835 9/22/2014 65290 9/30/2014 56956 6/18/2016 57666 6/23/2016 71060 10/13/2016 68943 10/26/2016 79065 11/9/2017 79842 1/25/2018 80908 2/15/2018
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.