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Terminated

Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.

FDA Recall Z-0160-04 · Posted 2003-11-27

Recalling FirmVygon US LLC
Recall StatusTerminated
Product CodeFOZ
Date Initiated2003-09-09
Date Terminated2003-11-26
Product Quantity3 units

Reason for Recall

mislabeled as sterile

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K853370H-H CATHETER PASSERS(TACL DESIGNHolter-Hausner Intl. · 1985-09-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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