OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Failure Risk
OriGen Biomedical is recalling 61 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection from the hub caused by adhesive failure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 according to the rubric. The potential for immediate disconnection of a critical life-support device represents a significant injury risk.
Plain-English summary
OriGen Biomedical, Inc. is recalling 61 units of the ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F. The affected lots are N18447-1A, P18909, and P18971. The product was distributed in 34 U.S. states and the District of Columbia, as well as in 19 foreign countries including Canada, the United Kingdom, and Germany.
The recall was initiated because 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 that have received these specific lots should stop using the affected cannulas and contact OriGen Biomedical for instructions on return or replacement. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — ECMO Cannula
- Affected units
- 61
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 (3)
- Lots: N18447-1A
- P18909
- P18971
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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