Device product
Lap Gallbladder Pack, part number AMS3707
Z-1326-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 225 kits
- Official record key
device-enforcement:Z-1326-2017
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 100414, 10/20/2019 84309, 5/14/2018 84891, 6/9/2018 85661, 7/14/2018 86668, 9/5/2018 87290, 8/9/2019 88195, 11/15/2018 94578, 12/14/2018 95117, 3/6/2019 97136, 5/29/2019 98513, 6/2/2019 99066, 6/20/2019
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.