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Terminated

Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106

FDA Recall Z-1067-03 · Posted 2003-07-30

Recalling FirmDeltec, Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2003-07-08
Date Terminated2004-07-02

Reason for Recall

Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.

Firm Action

A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.

Root Cause

Other

Distribution Pattern

The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904334PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KITPharmacia Deltec, Inc. · 1990-11-05

Official Source

View FDA Recall →

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

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