Z-1358-2017 Class II Terminated
FDA device recall Z-1358-2017 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: 120 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
- 120 kits
Product Description
Peri GYN, part number PSS2193(A
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 86291, 9/19/2017 87829, 10/7/2017 96967, 4/21/2018 98214, 6/19/2018 99585, 9/28/2018