Z-1299-2017 Class II Terminated
FDA device recall Z-1299-2017 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: 310 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
- 310 kits
Product Description
Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(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 100671, 9/28/2019 101398, 10/13/2019 84475, 5/26/2018 86027, 9/2/2018 87239, 9/5/2018 89280, 11/16/2018 95047, 1/24/2019 96991, 6/29/2019