Device product
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
Z-0270-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3104 kits
- Official record key
device-enforcement:Z-0270-2017
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: 61069 1/5/2015 57470 1/15/2015 64162 1/20/2015 66792 1/31/2015 61312 2/27/2015 66392 2/27/2015 59327 4/24/2015 60099 7/15/2015 61872 7/26/2015 60277 8/24/2015 60278 8/24/2015 61393 9/7/2015 63201 9/15/2015 61394 10/14/2015 62762 11/3/2015 61940 11/17/2015 62155 11/23/2015 64557 11/27/2015 61280 11/27/2015 61279 11/28/2015 61392 11/30/2015 66184 12/24/2015 65278 12/27/2015 63178 1/3/2016 63994 1/13/2016 64601 1/13/2016 64643 1/17/2016 63782 1/23/2016 63783 1/23/2016 73045 1/29/2016 69613 2/19/2016 69677 4/9/2016 70513 4/11/2016 76391 4/13/2016 74109 4/24/2016 57074 5/25/2016 76644 5/30/2016 57513 6/20/2016 71983 7/15/2016 67297 7/20/2016 67764 7/20/2016 58232 7/24/2016 58465 7/25/2016 77327 7/26/2016 77744 7/30/2016 78161 7/30/2016 65887 8/1/2016 67940 8/23/2016 68760 9/22/2016 70301 9/22/2016 70693 10/7/2016 69712 10/26/2016 68631 10/31/2016 71525 12/18/2016 71460 1/3/2017 72471 1/10/2017 72320 1/15/2017 70770 1/21/2017 72628 1/21/2017 73287 1/23/2017 72147 1/24/2017 72387 1/26/2017 72082 1/26/2017 72859 3/9/2017 72963 3/28/2017 73114 3/28/2017 76279 4/24/2017 76886 4/24/2017 74673 5/22/2017 75245 6/21/2017 76449 7/14/2017 77055 7/19/2017 77333 8/11/2017 78762 9/19/2017 78747 9/20/2017 79341 11/19/2017 79919 1/23/2018 73790 (no date was provided)
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.