Z-0055-06

Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr...

Name: Z-0055-06 Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr...
Creator: Origen Biomedical, Inc
Published: 2002-12-16
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2002-12-16 / Terminated

FDA source

Origen Biomedical, Inc began a recall of Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744 on 2002-12-16. The reason FDA records is "Leak between two lumens causes reduced performance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0055-06
Status: Terminated
Initiated: 2002-12-16
Posted: 2005-10-15
Terminated: 2005-11-03
Recalling firm: OriGen Biomedical, Inc.
Product: Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Leak between two lumens causes reduced performance.
FDA root cause: Other
Action: The recall was initiated by letter to all consignees on 12/16/2002.
Quantity in commerce: 170 catheters
Distribution: 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.
Product codes and lots: Model V V 12F; Lot Number 36BC20121

Product code DQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)