Device product
General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room
Z-0196-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1378 kits
- Official record key
device-enforcement:Z-0196-2017
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: 66206 2/25/2015 61424 8/18/2015 63370 11/2/2015 58543 11/8/2015 65418 11/9/2015 63596 11/11/2015 61749 11/22/2015 63420 1/4/2016 64414 1/9/2016 64968 1/13/2016 56888 5/22/2016 56889 5/23/2016 57341 6/8/2016 68248 7/11/2016 58351 7/14/2016 67619 7/16/2016 67417 8/9/2016 57586 8/14/2016 70741 9/5/2016 70742 9/5/2016 68659 9/21/2016 69502 9/23/2016 70631 9/24/2016 69732 9/26/2016 69073 9/27/2016 68295 9/28/2016 68059 9/29/2016 70630 10/23/2016 71024 12/10/2016 71126 12/17/2016 72093 1/7/2017 70999 1/18/2017 73785 1/27/2017 73806 4/5/2017 73807 4/9/2017 74111 4/10/2017 73618 4/20/2017 76130 7/15/2017 81087 1/9/2018
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.