OriGen recalls Reinforced Dual Lumen Cannula (19Fr, REF: VV19F) due to potential barium sulfate omission and incorrect tip length. Affected units sold with specific UDI and lot numbers. Consumers should contact manufacturer for details.
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 Cannulas that may lack barium sulfate and have a shorter tip than labeled. This could lead to improper use during medical procedures, potentially causing complications if used without the correct components.
The cannulas might not contain barium sulfate, which is critical for certain medical applications. Additionally, the actual tip length could be one centimeter shorter than printed, potentially affecting proper placement and function during critical procedures.
Healthcare professionals using these cannulas for extracorporeal life support procedures are most at risk. Patients receiving this equipment during critical medical treatments may be affected.
Check for the UDI code 00816203022097 and lot numbers N18394, N18447, N1:8447-1, N18447-1A, P18909, or P18971 on the packaging or label. These units were sold with specific sterilization and indication details.
Look for the UDI code 00816203022097 and lot numbers N18394, N18447, N18447-1, N18447-1A, P18909, or P18971 on the packaging or label.
These cannulas may lack barium sulfate and have a tip length one centimeter shorter than printed, which could affect proper medical use during critical procedures.
Check for the UDI code 00816203022097 and lot numbers N18394, N18447, N18447-1, N18447-1A, P18909, or P18971 on the packaging or label.
The recall does not specify a remedy, so contact OriGen Biomedical, Inc. directly for further instructions.
We’ve drafted a message you can send OriGen to request your refund or repair — edit it as you like.
Subject: Recall Z-0181-2019 — OriGen OriGen Hello, I own a OriGen that is covered by recall Z-0181-2019 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.
