Device product
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
Z-2905-2016
Product summary
- Event
- Event 75065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2905-2016
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 VC-1, Lot #0195451 with expiry 05/2019
Distribution pattern: Nationwide Distribution to KS only
Derived failure modes
-
Labeling or packaging
incomplete packaging