Z-0161-04

Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle

Name: Z-0161-04 Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle
Creator: Vygon US LLC
Published: 2003-09-09
License: https://open.fda.gov/license/

Phoenix Biomedical Corp. / initiated 2003-09-09 / Terminated / root cause: labeling and UDI

FDA source

Vygon US LLC began a recall of Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle on 2003-09-09. The reason FDA records is "mislabeled as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0161-04
Status: Terminated
Initiated: 2003-09-09
Posted: 2003-11-27
Terminated: 2003-11-26
Recalling firm: Phoenix Biomedical Corp.
Product: Reusable Catheter Passer (60 cm) SP02. One stainless steel catheter passer with T handle.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: mislabeled as sterile
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Catalog number SP02. Lot numbers H0266, H0464, H0565, H0650, I0195, J0288, J0108, J0494, K0701, and K0929.

Product code FOZ

K853370Class IH-H Catheter Passers(tacl DesignHolter-Hausner Intl. / cleared 1985-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)