Devices

Device Recall Outback Percutaneous catheter

Model / Serial
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 Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Sent mainly to Area sales representatives.
Product Description
LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
Manufacturer
Lumend Inc
1 Event
- Recall of Device Recall Outback Percutaneous catheter

Manufacturer

Lumend Inc

Manufacturer Address
Lumend Inc, 400 Chesapeake Dr, Redwood City CA 94063-4739
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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