Z-1793-2017 Class II Terminated
FDA device recall Z-1793-2017 was initiated by Windstone Medical Packaging, Inc. on March 16, 2017 and is designated Class II. Reason for recall: AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised. The recall status is terminated (terminated June 6, 2017). Affected quantity: 700 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 16, 2017
- Termination Date
- June 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 700 kits
Product Description
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Reason for Recall
AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
Distribution Pattern
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Code Information
Lot numbers: 81885 84227 89474 98076 99390