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Terminated

Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744

FDA Recall Z-0055-06 · Posted 2005-10-15

Recalling FirmOrigen Biomedical, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2002-12-16
Date Terminated2005-11-03
Product Quantity170 catheters

Reason for Recall

Leak between two lumens causes reduced performance.

Firm Action

The recall was initiated by letter to all consignees on 12/16/2002.

Root Cause

Other

Distribution Pattern

The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany.

Official Source

View FDA Recall →

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

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