Device product
Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
Z-0265-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3142 kits
- Official record key
device-enforcement:Z-0265-2017
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 Number/ Expiration Date: 61268 4/17/2014 58664 4/10/2015 59825 8/30/2015 61858 11/9/2015 64825 11/10/2015 64826 11/15/2015 66761 11/20/2015 64827 11/21/2015 63483 11/23/2015 59800 11/24/2015 63482 12/6/2015 62873 12/18/2015 65631 12/30/2015 64536 1/5/2016 63481 1/6/2016 63800 1/7/2016 66762 2/5/2016 66763 3/1/2016 67345 6/17/2016 75666 6/25/2016 68684 6/26/2016 66755 7/5/2016 78206 7/30/2016 67334 8/9/2016 60594 8/19/2016 68146 9/15/2016 69196 9/16/2016 70378 9/27/2016 70812 10/17/2016 71784 10/19/2016 71471 11/6/2016 72148 12/3/2016 71157 12/20/2016 71970 12/21/2016 74621 1/14/2017 72889 1/21/2017 73855 1/30/2017 73854 2/5/2017 72495 2/8/2017 72725 3/5/2017 75398 4/19/2017 74872 4/24/2017 76184 4/27/2017 75108 4/29/2017 74121 5/9/2017 75399 5/16/2017 77316 7/12/2017 77104 7/28/2017 77416 8/3/2017 77417 8/9/2017 77407 8/24/2017 77408 8/24/2017 77775 9/2/2017 78643 10/3/2017 76478 10/25/2017 80532 12/6/2017 79831 12/18/2017 79347 1/16/2018
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.