Device product
Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
Z-0145-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2266 kits
- Official record key
device-enforcement:Z-0145-2017
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: 57202 6/5/2016 57594 7/18/2016 58486 8/2/2016 58745 8/27/2016 59099 3/1/2015 59975 7/18/2015 60444 9/13/2015 60705 8/3/2015 61043 8/20/2015 61552 11/27/2015 62834 11/7/2015 63155 11/27/2015 63156 1/2/2016 64068 11/23/2015 64504 11/10/2015 65556 11/9/2015 65855 11/6/2015 66687 11/26/2015 67232 11/18/2015 67233 8/10/2016 67579 8/22/2016 68618 7/11/2016 68940 9/12/2016 69988 9/23/2016 71297 9/12/2016 71430 12/25/2016 71814 12/13/2016 72034 3/13/2017 73741 4/3/2017 74154 4/26/2017 74893 5/4/2017 75440 5/14/2017 75692 7/12/2017 76228 7/3/2017 76544 7/29/2017 76710 8/29/2017 77124 9/23/2017 79188 9/16/2017 79450 1/9/2018 79755 2/28/2018
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.