Device product
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
Z-2906-2016
Product summary
- Event
- Event 75065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-2906-2016
Official wording
Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information: Catalog Number F75221, Lot #0195486 with expiry 04/2021
Distribution pattern: Nationwide Distribution to KS only
Derived failure modes
-
Labeling or packaging
incomplete packaging