Agency classClass IOur severity:Severe FDA (Devices)·Z-1227-2019·Announced 2019-06-12

OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Failure Risk

OriGen Biomedical is recalling 260 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection caused by adhesive failure.

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 260 units of the ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F. The recall involves specific lots: N18446, N18640-1, R19208, and R19406. The product was distributed across 35 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 specific lots should stop using the affected cannulas and contact OriGen Biomedical for instructions on return or replacement. Patients who have received these devices should consult their healthcare provider regarding the recall.

The recalled product

Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
Manufacturer: OriGen Biomedical, Inc.
Category: Medical Device — ECMO Cannula
Hazard: adhesive-failure
tube-disconnect
Affected units: 260

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: N18446
N18640-1
R19208
R19406

Distribution

Distributed in 33 states:

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.

See all 6 products in this recall →

Same manufacturer · OriGen Biomedical, Inc.

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OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect
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OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect
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Same hazard · adhesive failure