Device product
Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room
Z-0262-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1164 Kits
- Official record key
device-enforcement:Z-0262-2017
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 Number/ Expiration Date: 58302 3/26/2014 59046 6/9/2014 60228 6/15/2014 60559 6/20/2014 63222 8/14/2014 61004 9/13/2014 61491 9/21/2014 63003 12/11/2014 64005 2/14/2015 63768 2/22/2015 64592 3/18/2015 65494 5/30/2015 67289 6/11/2015 67602 8/14/2015 68438 8/22/2015 68275 8/25/2015 69589 10/22/2015 70504 10/24/2015 71258 12/7/2015 71749 12/19/2015 72506 2/15/2016 72750 2/22/2016 74081 2/24/2016 73436 2/28/2016 56986 5/24/2016 76902 6/20/2016 77188 9/9/2016 77986 9/18/2016 78514 9/19/2016 79246 9/26/2016 80549 10/27/2016
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.