OriGen recalls Reinforced Dual Lumen Cannula (16Fr) due to possible barium sulfate omission and catheter tip length error. Affected units have specific UDI and lot numbers. 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 Reinforced Dual Lumen Cannula (16Fr) because some units may lack barium sulfate and have a catheter tip that's one centimeter shorter than labeled. This could lead to improper medical use during critical procedures.
The cannula may lack barium sulfate, which is critical for certain medical procedures. Additionally, the actual tip length is one centimeter shorter than printed, potentially causing improper placement or function during life support.
Healthcare professionals using the cannula for extracorporeal life support procedures. Patients receiving this device during critical medical treatments are at risk if the device is used incorrectly.
Check for the UDI code 00816203022073 and lot numbers N18404, N18446, N1:18640, N18640-1, R19208 on the packaging or label. The product is intended for use in extracorporeal life support procedures.
Look for the UDI code 00816203022073 and lot numbers N18404, N18446, N18640, N18640-1, R19208 on the packaging or label.
The recall is due to possible barium sulfate omission and a catheter tip that is one centimeter shorter than printed on the label.
Check the product for the UDI code 00816203022073 and lot numbers N18404, N18446, N18640, N18640-1, R19208. If you have the affected units, contact OriGen for further instructions.
The recall record does not specify a remedy, so contact OriGen directly for guidance.
We’ve drafted a message you can send OriGen to request your refund or repair — edit it as you like.
Subject: Recall Z-0180-2019 — OriGen OriGen Hello, I own a OriGen that is covered by recall Z-0180-2019 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.
