Device product
Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
Z-0152-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 312 kits
- Official record key
device-enforcement:Z-0152-2017
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 NumbersExpiration Dates: 58626 10/25/2014 61076 5/14/2015 62460 6/4/2015 63884 6/6/2015 63742 6/11/2015 65028 6/12/2015 63220 6/18/2015 66436 11/27/2015 65659 11/30/2015 57175 5/16/2016 67267 5/17/2016 72357 5/25/2016 72480 7/21/2016 78609 1/17/2017
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.