Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
FDA device recall Z-0160-04 · posted 2003-11-27 · Terminated
Recall details
- Recalling firm
- Vygon US LLC
- Reason for recall
- mislabeled as sterile
- Action taken
- The recalling firm issued recall letters to their direct accounts via fax on 9/9/03. The letter informed the accounts of the problem and the need to sterilize the product or return it for replacements.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 3 units
- Distribution
- The products were shipped to one distributor in NY and two hospitals in TX and UT. The products were also shipped to distributors in Holland, Greece, Austria, Norway, Taiwan, and Finland.
- Date initiated
- 2003-09-09
- Date posted
- 2003-11-27
- Date terminated
- 2003-11-26
- 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 CATHETER PASSERS(TACL DESIGN (K853370) | Holter-Hausner Intl. | 1985-09-18 |