Device product
Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room
Z-0173-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 kits
- Official record key
device-enforcement:Z-0173-2017
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: 61836 6/30/2013 58821 9/2/2013 60583 11/1/2013 62371 3/8/2014 65618 4/16/2014 64076 4/20/2014 67477 7/11/2014 69351 10/2/2014 69593 12/20/2014 72030 2/2/2016 73144 2/17/2016 72643 2/28/2016 74897 5/31/2016 77971 6/16/2016 76042 6/20/2016 56380 6/25/2016
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.