Device product
Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
Z-0155-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1498 kits
- Official record key
device-enforcement:Z-0155-2017
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: 59278 10/2/2013 58407 10/14/2013 62436 12/4/2013 62922 12/18/2013 60740 5/20/2014 63467 6/2/2014 62067 6/7/2014 64703 6/10/2014 61619 6/14/2014 64110 6/14/2014 63539 6/29/2014 65271 7/8/2014 65364 7/11/2014 65837 7/31/2014 70246 9/3/2014 70351 9/4/2014 69850 9/7/2014 67400 9/11/2014 69434 9/18/2014 71639 9/18/2014 68310 9/30/2014 72944 10/1/2014 71948 10/9/2014 71949 10/22/2014 65894 2/7/2015 68624 3/12/2015 77600 8/12/2015 76292 8/14/2015 72862 10/5/2015 73989 10/7/2015 67704 12/5/2015 73680 1/3/2016 74974 1/7/2016 76004 1/9/2016 75570 1/17/2016 73628 1/24/2016 73982 2/3/2016 74027 2/24/2016 74377 3/26/2016 75655 3/29/2016 79047 4/5/2016 78542 4/14/2016 78888 4/27/2016 77381 4/30/2016 57192 5/30/2016 57138 6/4/2016 78207 6/20/2016 71656 8/3/2016 75175 8/19/2016 77224 8/23/2016 74582 9/9/2016 78973 10/28/2016 79324 11/16/2016 79137 11/25/2016
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.