OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect
OriGen Biomedical is recalling 66 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub if clamped improperly.
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 recall involves a Class I medical device defect where a component disconnect could lead to serious injury or death, meeting the criteria for a Severe rating.
Plain-English summary
OriGen Biomedical, Inc. is recalling 66 units of ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F. The recall involves lots P18806 and R19368. The products were distributed to 34 U.S. states and the District of Columbia, as well as 20 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 that have received these products should stop using them and contact the manufacturer for instructions on return or replacement. Patients who have had these devices implanted should contact their healthcare provider for evaluation.
The recalled product
- Product
- ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — ECMO Cannula
- Affected units
- 66
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: P18806
- R19368
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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