Device product
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
Z-1788-2017
Product summary
- Event
- Event 76774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,170 kits
- Official record key
device-enforcement:Z-1788-2017
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: 75870 78661 79154 81580 81800 83500 83594 83680 84118 84262 86073 86485 86887 87119 89180 95109 95422 95809 96760 97589 98512 99060 100410 101234
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