The Recall Desk
HighFDA (Devices)·Z-1232-2019·Announced 2019-06-12

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.

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) where a structural failure could lead to serious harm, but the source text does not report any specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

OriGen Biomedical, Inc. is recalling 66 units of the ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F. The recall affects specific lots: N18487, N18487-1, N18561-1, and R19169. The products were distributed across numerous U.S. states and foreign countries, including the UAE, Saudi Arabia, and Canada.

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 recalling firm for further instructions. Consumers should not use these prescription-only medical devices.

The recalled product

Product
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Manufacturer
OriGen Biomedical, Inc.
Category
Medical Device — ECMO Cannula
Hazard
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 (4)

  • Lots: N18487
  • N18487-1
  • N18561-1
  • R19169

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 →

Related recalls

Same manufacturer · OriGen Biomedical, Inc.

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Same hazard · structural failure

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