Agency classClass IOur severity:Severe FDA (Devices)·Z-1228-2019·Announced 2019-06-12

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.

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 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
Hazard: disconnection
adhesive-failure
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

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 Adhesive Failure Risk
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OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect
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Same hazard · disconnection