Device product
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
Z-0156-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 505 kits
- Official record key
device-enforcement:Z-0156-2017
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: 59572 3/1/2015 58932 4/24/2015 57078 7/8/2015 57694 7/14/2015 60620 8/4/2015 61768 11/4/2015 67414 11/16/2015 65034 1/17/2016 75189 4/16/2016 76805 4/17/2016 57372 6/19/2016 57636 6/20/2016 66625 7/29/2016 67295 9/27/2016 71082 9/28/2016 71404 12/21/2016 72826 1/16/2017 72162 1/27/2017 75661 6/18/2017 76889 7/16/2017 77066 7/19/2017 81026 1/13/2018 79638 1/9/2019
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.