Z-1278-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2017
- Initiation Date
- January 11, 2017
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 kits
Product Description
Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A
Reason for Recall
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.
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.
Code Information
Lot number and expiration date 100592, 9/7/2019 96541, 6/16/2019 97532, 5/7/2019 97836, 6/4/2019 98247, 6/15/2019 98788, 6/29/2019