Device product
Basin Pack, part number AMS2497
Z-1272-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 648 kits
- Official record key
device-enforcement:Z-1272-2017
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 84187, 5/14/2018 84938, 6/30/2018 85835, 9/12/2018 86871, 8/14/2019 87444, 9/30/2018 88377, 11/15/2018 88626, 10/8/2018 89025, 12/10/2018 89575, 1/30/2019 94929, 3/6/2019 96912, 5/5/2019 97575, 6/22/2019 97652, 9/27/2019
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.