Device product
Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room
Z-0186-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720 kits
- Official record key
device-enforcement:Z-0186-2017
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 56700 2/25/2014 57515 4/17/2014 62330 8/13/2014 61942 8/29/2014 59216 10/8/2014 63015 1/2/2015 62624 1/6/2015 68055 6/9/2015 66922 6/26/2015 68289 8/28/2015 68448 10/13/2015 72101 11/18/2015 72971 2/28/2016 75676 5/16/2016 76488 9/4/2016 78162 11/13/2016 79264 1/6/2017
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.