Device product
Plastic Pack, part numbers AMS1028, AMS1028(A, and WAL1189. Product packaged in a convenient manner for use in a general clinical procedure
Z-1796-2017
Product summary
- Event
- Event 76774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 376 kits
- Official record key
device-enforcement:Z-1796-2017
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: 76028 76762 77415 77811 80676 81907 82972 83238 84514 86860 88156 89013 89567 94566 95941 97769 98479 99356 101279 102974
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