Device product
Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
Z-0174-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 648 kits
- Official record key
device-enforcement:Z-0174-2017
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: 65805 2/24/2015 59138 8/31/2015 61015 9/17/2015 65118 10/20/2015 65413 11/3/2015 66234 11/8/2015 66921 11/29/2015 57959 8/15/2016 69802 9/27/2016 68607 10/5/2016 71901 10/19/2016 71111 12/26/2016 72510 3/14/2017 76252 4/14/2017 76892 4/23/2017 74517 5/15/2017 73799 5/24/2017 75239 7/15/2017 77363 8/25/2017
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.