OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Bond Failure
OriGen Biomedical is recalling 72 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
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ECMO cannula) with a potential for serious injury due to disconnection, but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
OriGen Biomedical, Inc. is recalling 72 units of the ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F. The affected lots are N18431, N18431-1, R19280, and R19281. The product was distributed to 33 U.S. states and the District of Columbia, as well as 20 foreign countries.
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 facilities and distributors should stop using the affected devices and contact OriGen Biomedical for further instructions. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — ECMO Cannula
- Affected units
- 72
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 (4)
- Lots: N18431
- N18431-1
- R19280
- R19281
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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