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Terminated

Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022

FDA Recall Z-0280-2007 · Posted 2006-12-19

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJT
Date Initiated2006-09-29
Date Terminated2007-06-04
Product Quantity1924

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.

K933316THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEMTherex Corp. · 1994-02-23K790882LEAD INTRODUCER SETIntrostat · 1979-06-11

Official Source

View FDA Recall →

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

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