Device product
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
Z-1784-2017
Product summary
- Event
- Event 76774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 990 kits
- Official record key
device-enforcement:Z-1784-2017
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: 77429 79999 81143 81960 84055 84556 85169 85550 86501 87632 87819 96056 96963 97873 98741 99416 99763 100278 101449
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