Device product
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Z-2908-2016
Product summary
- Event
- Event 75065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-2908-2016
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 910122, Lot #0195615 with expiry 04/2019
Distribution pattern: Nationwide Distribution to KS only
Derived failure modes
-
Labeling or packaging
incomplete packaging