Device product
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
Z-0221-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 230 kits
- Official record key
device-enforcement:Z-0221-2017
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: 57846 11/27/2014 58334 11/16/2014 60660 7/21/2015 61766 7/22/2015 62797 10/20/2015 63414 1/30/2016 66908 11/26/2015 67932 4/9/2016 68546 6/11/2016 71757 9/7/2016 72106 9/2/2016 72622 8/25/2016 73283 8/5/2016 73423 8/13/2016 73765 8/2/2016 74067 8/16/2016 74310 12/8/2016 75360 2/4/2017
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.