Z-1260-2017 Class II Terminated
FDA device recall Z-1260-2017 was initiated by Windstone Medical Packaging, Inc. on January 11, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 3, 2017). Affected quantity: 51 kits.
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
- 51 kits
Product Description
Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C
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 numbers and Expiration dates: 84343, 5/20/2018 88052, 11/11/2018 89579, 11/15/2018 89709, 12/10/2018 94934, 1/4/2019 95441, 6/3/2019