Z-1369-2017 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
- 875 kits
Product Description
Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(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 100412, 8/14/2018 100837, 10/19/2019 101181, 10/9/2019 83278, 5/27/2018 83634, 5/20/2017 84945, 6/24/2017 85147, 7/28/2017 85150, 7/15/2018 85258, 6/10/2018 85541, 7/14/2018 85554, 7/2/2018 85555, 7/7/2018 86259, 7/2/2017 86308, 9/20/2018 86488, 10/29/2018 86512, 9/28/2018 86688, 11/16/2019 86747, 8/3/2018 87122, 10/7/2017 87798, 10/28/2017 88399, 10/19/2017 88404, 11/20/2018 89040, 12/14/2017 89088, 12/10/2018 89598, 11/18/2018 89887, 12/16/2018 95111, 12/12/2017 95287, 6/15/2019 95811, 2/23/2018 96607, 1/7/2018 97133, 2/7/2018 97290, 5/22/2019 98325, 3/26/2018 98687, 6/14/2019 99065, 6/13/2018 99548, 9/27/2019