Z-1272-2017 Class II Terminated
FDA device recall Z-1272-2017 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: 648 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
- 648 kits
Product Description
Basin Pack, part number AMS2497
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 84187, 5/14/2018 84938, 6/30/2018 85835, 9/12/2018 86871, 8/14/2019 87444, 9/30/2018 88377, 11/15/2018 88626, 10/8/2018 89025, 12/10/2018 89575, 1/30/2019 94929, 3/6/2019 96912, 5/5/2019 97575, 6/22/2019 97652, 9/27/2019