Z-1319-2017 Class II Terminated
FDA device recall Z-1319-2017 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: 130 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
- 130 kits
Product Description
Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(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 100452, 9/8/2019 100934, 10/6/2019 84549, 5/10/2018 86945, 3/9/2019 95425, 5/20/2019 99399, 6/16/2019 99741, 9/25/2019