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Terminated

LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.

FDA Recall Z-0995-04 · Posted 2004-07-20

Recalling FirmLumend Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2004-05-18
Date Terminated2004-07-26
Product QuantityQuantity distributed = 122 catheters.

Reason for Recall

Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.

Firm Action

Area Sales managers were contacted via phone conference on 05/18/04 and instructed to quarantine all outback catheters in their possession and notify all customers with any outback inventory to quarantine the product and make arrangements to retrieve the product from them.

Root Cause

Other

Distribution Pattern

Sent mainly to Area sales representatives.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032298MODIFICATION TO OUTBACK CATHETERLumend, Inc. · 2003-08-26

Official Source

View FDA Recall →

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

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