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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 134
Distribution
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