OriGen Reinforced Dual Lumen Catheter Recalled for Tube Separation
OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.
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 that the adverse events resulted in patient injury (blood loss), which meets the rubric criteria for a score of 4 (Severe) due to significant injury reports.
Plain-English summary
OriGen Biomedical, Inc. is recalling 180 units of the OriGen Reinforced Dual Lumen catheter (RDLC). The device is a dual lumen catheter with a wire reinforcement layer on the tip, covered by a heat-shrunk sheath. The recall affects specific lot numbers N18487 and N18487-1.
The recall was initiated after two users reported that the clear extension tube separated from the hub connection on the VV28F OriGen Reinforced Dual Lumen ECMO Catheter. These adverse events resulted in patient injury, specifically blood loss.
The affected products were distributed in the United States and in Austria, Belgium, Chile, the Czech Republic, Italy, the Kingdom of Saudi Arabia, the Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, and the United Arab Emirates. Users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 180
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 (2)
- Lot Numbers: N18487
- N18487-1
Distribution
Distributed nationwide across the United States.
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