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Terminated

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014

FDA Recall Z-0285-2007 · Posted 2006-12-19

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJT
Date Initiated2006-09-29
Date Terminated2007-06-04
Product Quantity94

Reason for Recall

Catheter has separated from the infusion port body.

Firm Action

The recall notification was sent out to their US customers on 9/29/2006.

Root Cause

Other

Distribution Pattern

Nationwide. The firm is NOT recalling from international accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K926011A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODITherex Corp. · 1993-03-19K921379A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXTTherex Corp. · 1992-11-06

Official Source

View FDA Recall →

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

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