OriGen Reinforced Dual Lumen Cannula Recalled for Potential Tube Separation
OriGen Biomedical is recalling 134 units of the VV19F Reinforced Dual Lumen Cannula because the extension tube may separate from the hub, posing a risk of blood loss.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the recall as 'Class I' by the FDA, which mandates a severity score of 5 according to the rubric. Additionally, the hazard involves potential blood loss and permanent impairment, which are serious injury risks.
Plain-English summary
OriGen Biomedical, Inc. is recalling 134 units of the REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO. The product is identified by Lot N18394 and UDI 00816203022097. The device 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.
The recall is due to a potential for the clear extension tube to separate from the hub. This defect could result in blood loss and may require intervention to prevent permanent impairment or damage. The agency has classified this as a Class I recall.
The affected units were distributed worldwide, including in the United States (AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI) and in Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain, Sweden, Thailand, and the United Kingdom. Healthcare facilities and users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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 extra
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 134
Distribution
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