Z-0995-04

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

Name: Z-0995-04 LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas
Creator: Lumend Inc
Published: 2004-05-18
License: https://open.fda.gov/license/

Lumend, Inc. / initiated 2004-05-18 / Terminated

FDA source

Lumend Inc began a recall of LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas on 2004-05-18. The reason FDA records is "Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0995-04
Status: Terminated
Initiated: 2004-05-18
Posted: 2004-07-20
Terminated: 2004-07-26
Recalling firm: Lumend, Inc.
Product: LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
Product code: DQY Catheter, Percutaneous
Reason for recall: Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
FDA root cause: Other
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.
Quantity in commerce: Quantity distributed = 122 catheters.
Distribution: Sent mainly to Area sales representatives.
Product codes and lots: Model number OTB 1235, Dates of manufacture 11-2003, 03-2004 and 04-2004. Model number OTB 1245, Dates of manufacture 11-2003. 510(k) K032298.

Product code DQY

K032298Class IIModification to Outback CatheterLumend, Inc. / cleared 2003-08-26

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)