Device product
Hip Pack (1347), part number AMS6564
Z-1316-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 kits
- Official record key
device-enforcement:Z-1316-2017
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 101253, 10/15/2018
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.