Agency classClass IIOur severity:High FDA (Devices)·Z-0183-2019·Announced 2018-10-24

OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

OriGen Biomedical is recalling 241 units of ECMO Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 used for extracorporeal life support with manufacturing deficiencies (missing radiopaque material and inaccurate dimensions) that could impact clinical safety, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

OriGen Biomedical, Inc. is recalling 241 units of the ECMO Reinforced Dual Lumen Cannula, 28Fr. (REF: VV28F). The affected devices are sterile and intended for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.

The recall was initiated because the catheters may have two specific deficiencies: the omission of barium sulfate and an actual catheter tip length that is one centimeter shorter than what is printed on the tip. The affected lots include N18487, N18487-1, N18561-1, and R19169, with UDI 00816203022124.

The devices were distributed nationwide in the United States to numerous states and internationally to countries including Canada, the United Kingdom, Germany, and Japan. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product: ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
Manufacturer: OriGen Biomedical, Inc.
Category: Medical Device — Catheter
Hazard: manufacturing-defect
inaccurate-labeling
Affected units: 241

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 (5)

UDI: 00816203022124
Lot: N18487
N18487-1
N18561-1
R19169

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

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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