OriGen recalls Reinforced Dual Lumen Cannulas with potential barium sulfate omission and incorrect tip length. Affected units include specific lot numbers for ECMO procedures. Contact for replacement.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
OriGen is recalling certain reinforced dual lumen cannulas used in ECMO procedures due to possible missing barium sulfate and a shorter catheter tip than labeled. This could lead to improper blood flow or clotting during critical medical treatments.
The cannulas may lack barium sulfate, which is critical for imaging during procedures. The tip length is also one centimeter shorter than printed, potentially causing improper placement in the vein.
Healthcare professionals using these cannulas for ECMO procedures are most at risk. Patients receiving ECMO support may be affected if the cannula is used without proper verification.
Check for the model number VV13F, sterile EO, and lot numbers N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, N18573. These are used in ECMO procedures for blood drainage and re-infusion.
Verify the lot numbers and model (VV13F) to confirm if your cannula is affected.
The cannulas may have missing barium sulfate and an incorrect tip length, which could affect proper blood flow during ECMO procedures.
Check the lot numbers and model to see if it's affected; contact OriGen for replacement if needed.
The recall is for medical use only; patients are not directly affected unless the cannula is used without proper verification.
We’ve drafted a message you can send OriGen to request your refund or repair — edit it as you like.
Subject: Recall Z-0179-2019 — OriGen OriGen Hello, I own a OriGen that is covered by recall Z-0179-2019 from OriGen. 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.
