OriGen recalls ECMO Reinforced Dual Lumen Cannulas with possible barium sulfate omission and shorter tip length than labeled. Affected units have UDI 0081620:203022124 and specific lots. Contact for remedy.
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 ECMO cannulas that might lack barium sulfate and have a tip one centimeter shorter than marked. This could lead to improper use during critical medical procedures.
The cannula may lack barium sulfate, which is critical for certain medical applications. The tip is also one centimeter shorter than labeled, potentially causing improper placement during critical procedures.
Healthcare professionals using these cannulas for extracorporeal life support procedures. Patients receiving ECMO treatment are at risk if the cannula is used incorrectly.
Check for the UDI code 00816203022124 and lots N18487, N18487-1, N18561-1, R19169. The product is a 28Fr ECMO Reinforced Dual Lumen Cannula from OriGen Biomedical.
Look for the UDI code 00816203022124 and specific lots listed in the recall notice.
The cannula may have barium sulfate omission and a tip one centimeter shorter than printed, which could affect proper use during ECMO procedures.
The recall notice does not specify a remedy, so contact OriGen Biomedical for further instructions.
Affected lots include N18487, N18487-1, N18561-1, and R19169.
We’ve drafted a message you can send OriGen to request your refund or repair — edit it as you like.
Subject: Recall Z-0183-2019 — OriGen OriGen Hello, I own a OriGen that is covered by recall Z-0183-2019 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.
