Device product
Custom Tray, part numbers PSS1111 and PSS1111(A. Product packaged in a convenient manner for use in a general clinical procedure
Z-1786-2017
Product summary
- Event
- Event 76774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 164 kits
- Official record key
device-enforcement:Z-1786-2017
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: 64496 70752 79598 79966 82199 84036 85170 86682 87625 88001 89215 96462 100885
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