OriGen Biomedical recalls reinforced dual lumen cannulas due to failed endotoxin testing. Affected units have specific model and lot numbers. Consumers should contact for details.
The catheter failed the endotoxin testing.
OriGen Biomedical is recalling reinforced dual lumen cannulas that failed endotoxin testing. This could pose a risk of infection or other complications if used in medical procedures.
Endotoxins are toxic substances found in the outer membrane of bacteria. If the cannula failed endotoxin testing, it could introduce harmful bacteria into the bloodstream during medical procedures, potentially causing infections or other complications.
Healthcare professionals using the cannulas for ECMO or other medical procedures are most at risk. Patients receiving these cannulas may also be affected.
Check for the model number VV13F, lot number N18687-1, and unique device identifier 00816203022059 on the cannula packaging or label.
Look for the model number VV13F, lot number N18687-1, and unique device identifier 00816203022059 on the cannula packaging or label.
The cannula failed endotoxin testing, which could introduce harmful bacteria into the bloodstream during medical procedures.
The recall record does not specify a remedy, so contact OriGen Biomedical directly for instructions.
The recall record does not describe a specific hazard mechanism that would cause serious injury, so the risk level is unknown.
We’ve drafted a message you can send OriGen Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0102-2019 — OriGen Biomedical OriGen Biomedical Hello, I own a OriGen Biomedical that is covered by recall Z-0102-2019 from OriGen Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
