Device product
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Z-1294-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 390 kits
- Official record key
device-enforcement:Z-1294-2017
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 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/2018 86480, 9/3/2018 86749, 9/21/2018 87287, 8/11/2019 88184, 9/4/2018 88318, 11/19/2018 88647, 10/5/2018 89495, 9/30/2019 89589, 12/10/2018 95103, 1/2/2019 96194, 1/18/2019 96922, 5/11/2019 97787, 6/9/2019 98676, 6/27/2019
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.