Device product
Catheter Pack, part number AMS4399(A
Z-1280-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1116 kits
- Official record key
device-enforcement:Z-1280-2017
Official wording
Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
Code information: Lot number and expiration date 84598 4/16/2017 84599 5/8/2018 85277 5/11/2018 85342 5/17/2018 85456 6/3/2018 85629 6/11/2018 85630 8/21/2018 87145 10/15/2018 89443 8/23/2018 89892 11/30/2018 95180 8/24/2018 95298 11/21/2018 95789 11/11/2018 96424 12/26/2018 96494 12/17/2018 96945 3/11/2019 97753 4/3/2019 97817 4/12/2019 98124 4/18/2019 98703 5/23/2019 98704 6/7/2019 98940 6/30/2019 99561 6/17/2019 99900 6/29/2019
Distribution pattern: Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Derived failure modes
-
Unknown
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.