Z-1312-2017 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
- 1416 kits
Product Description
Hand Tray, part number PSS2365(F Hand Tray, part number PSS2365(G
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 84418, 1/30/2017 85478, 5/15/2017 85479, 5/21/2017 86212, 1/27/2017 86213, 1/27/2017 86630, 1/14/2017 87353, 1/24/2017 87946, 1/30/2017 88345, 2/22/2017 89564, 2/19/2017 94774, 1/17/2017 95066, 1/30/2017 95322, 1/25/2017 95854, 2/18/2017 96363, 2/10/2017 96634, 2/7/2018 97251, 2/7/2018 97325, 2/18/2018 98448, 2/10/2018 98449, 5/12/2018 98450, 10/24/2018 98451, 10/24/2018 98452, 10/31/2018 98453, 10/30/2018 98576, 10/20/2018 98577, 4/16/2019