Device product
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Z-0160-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 186 kits
- Official record key
device-enforcement:Z-0160-2017
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: 59927 1/26/2013 67573 1/15/2014 65388 1/17/2014 66189 1/18/2014 64668 1/25/2014 68256 12/6/2014 72518 7/8/2015 75168 7/16/2015 73464 7/17/2015 77622 1/26/2016 76003 7/3/2016 77246 7/17/2016 76580 7/29/2016 74412 7/31/2016 72288 1/9/2017
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.