Z-1276-2017 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
- 1436 kits
Product Description
Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430
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 100634, 9/23/2018 83241, 6/20/2017 83757, 6/1/2017 84174, 1/14/2017 84249, 1/20/2017 84496, 6/21/2017 84521, 3/19/2017 84904, 4/28/2017 84910, 1/25/2017 85071, 11/30/2017 85126, 6/28/2017 85126, 6/28/2017 85162, 1/17/2017 85565, 1/24/2017 85634, 6/11/2017 85820, 3/25/2017 85831, 6/14/2017 85985, 7/15/2017 86062, 4/21/2017 86141, 3/19/2017 86656, 7/10/2017 86797, 2/5/2018 86862, 6/18/2017 87093, 6/26/2017 87110, 8/22/2017 87747, 3/21/2017 88532, 2/11/2018 89014, 9/9/2017 89155, 12/22/2017 89244, 12/13/2017 89569, 12/3/2017 89770, 5/3/2017 89932, 7/7/2017 94601, 5/16/2017 95184, 7/29/2017 95185, 5/12/2017 95224, 5/1/2017 95265, 3/20/2018 95623, 9/22/2017 95793, 12/1/2017 96299, 5/22/2019 96563, 3/28/2018 96987, 5/21/2017 97563, 12/22/2017 97564, 3/30/2018 97902, 2/9/2018 98436, 3/7/2018 98445, 12/25/2018 98900, 2/28/2018 98937, 9/12/2018 98980, 2/3/2018 99258, 3/8/2018