Z-1368-2017 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
- 606 kits
Product Description
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B
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 100823, 10/13/2019 100856, 9/5/2019 84375, 5/20/2018 84747, 7/23/2018 85059, 7/21/2018 85549, 7/13/2018 85838, 8/1/2018 86718, 9/5/2018 87103, 9/12/2018 87106, 9/15/2018 87277, 8/10/2019 87347, 6/22/2018 87916, 6/22/2019 87962, 11/15/2018 88047, 9/4/2018 88376, 12/29/2018 89418, 11/12/2018 94736, 1/21/2019 95273, 6/12/2019 96914, 6/15/2019 97450, 5/11/2019 98491, 9/27/2019 98503, 6/6/2019 99369, 9/27/2019