Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
REF VV19F Reinforced Dual Lumen Cannula Recalled by OriGen Biomedical, Inc. Due to Potential for clear extension tube to separate from...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OriGen Biomedical, Inc. directly.
Affected Products
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Quantity: 134
Why Was This Recalled?
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About OriGen Biomedical, Inc.
OriGen Biomedical, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report