Device Recall Outback Percutaneous catheter

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.

Cardiovascular Devices

2

No

Sent mainly to Area sales representatives.

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