Recall Z-0161-04 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Vygon US LLC
Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle.
| Date | Nov 27, 2003 (initiated Sep 9, 2003) |
| Status | Terminated |
| Reason | mislabeled as sterile |
| Root cause | Other |
| Action | 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. |
| Quantity | 26 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K853370 | H-H CATHETER PASSERS(TACL DESIGN Holter-Hausner Intl., Sep 18, 1985 |