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Terminated

Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.

FDA Recall Z-0721-2007 · Posted 2007-04-05

Recalling FirmUrologix, Inc.
Recall StatusTerminated
Product CodeMEQ
Date Initiated2007-03-16
Date Terminated2007-05-25
Product Quantity21

Reason for Recall

The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.

Firm Action

A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.

Root Cause

Other

Distribution Pattern

Nationwide and the Netherlands.

Official Source

View FDA Recall →

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

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