Device product
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Z-1793-2017
Product summary
- Event
- Event 76774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 kits
- Official record key
device-enforcement:Z-1793-2017
Official wording
Reason: 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.
Code information: Lot numbers: 81885 84227 89474 98076 99390
Distribution pattern: Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Derived failure modes
-
Sterility assurance
sterile packaging of the eye pad to be compromised