OriGen VV13F Reinforced Dual Lumen Catheter Recalled for Separation Risk
OriGen Biomedical is recalling 51 units of VV13F Reinforced Dual Lumen Catheters 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect 'may require intervention to prevent permanent impairment/damage,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4.
Plain-English summary
OriGen Biomedical, Inc. is recalling 51 units of the OriGen VV13F Reinforced Dual Lumen Catheter. The product is a sterile, disposable medical device indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
The recall was initiated due to a potential defect where the clear extension tube may separate from the hub. This separation could result in blood loss and may require medical intervention to prevent permanent impairment or damage.
The affected units are identified by Lot N18549. The products were distributed worldwide, including nationwide in the United States and in Spain, the UK, Germany, Sweden, and the Netherlands. Users should stop using the affected catheters and contact the manufacturer for further instructions.
The recalled product
- Product
- OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal…
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 51
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot N18549
Distribution
Distributed nationwide across the United States.
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