OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect
OriGen Biomedical is recalling 145 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate…"
Plain-English summary
OriGen Biomedical, Inc. is recalling 145 units of the ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F. The affected lots are N18573 and N18687-1. The recall covers units distributed across 34 US states and the District of Columbia, as well as 19 foreign countries.
The recall is due to a potential defect where clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, resulting in the clear tube disconnecting from the hub.
Healthcare providers and facilities should stop using the affected devices and contact OriGen Biomedical for further instructions.
The recalled product
- Product
- ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — ECMO Cannula
- Affected units
- 145
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)
- Lots: N18573
- N18687-1
Distribution
Part of a larger recall action
This product is one of 6 recalled by OriGen Biomedical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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