Lumend Inc LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
Brand
Lumend Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Lumend Inc is recalling LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas due to Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026