7 cm Catheter Reservoir with 10 cm extension
FDA device recall Z-0366-06 · posted 2006-01-10 · Terminated
Recall details
- Recalling firm
- Vygon Neuro
- Reason for recall
- stylet in package is shorter than that claimed on the label
- Action taken
- The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HCA
- Quantity affected
- 11 units
- Distribution
- The product was shipped to a hospital in CA and a distributor in Germany.
- Date initiated
- 2005-03-24
- Date posted
- 2006-01-10
- Date terminated
- 2006-01-10
- Location
- Norristown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER (K853362) | Holter-Hausner Intl. | 1985-09-03 |
| H-H VENTRICULAR CATHETERS & RESERVOIRS (K853361) | Holter-Hausner Intl. | 1985-08-28 |