Z-1283-2017 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
- 229 kits
Product Description
Custom Breast Augmentation Pack, part number PSS2455(D
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 100294, 5/29/2018 84142, 5/25/2017 85025, 5/25/2017 88222, 5/25/2017 88310, 5/25/2017 89226, 5/25/2017 96139, 7/6/2017 96969, 7/30/2017 97625, 7/27/2017