Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0182-2019·Announced 2018-10-24

OriGen Dual Lumen Cannula Recalled for Manufacturing Deficiencies

OriGen Biomedical is recalling 169 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

OriGen Biomedical, Inc. is recalling 169 units of the Reinforced Dual Lumen Cannula, 23Fr. (REF: VV23F, Sterile EO). The affected devices are identified by UDI 00816203022103 and Lot numbers N18431 and N18431-1. These medical devices are 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 procedures.

The recall was initiated because the catheters may have two specific manufacturing 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 omission of barium sulfate may affect the radiopacity of the device, while the discrepancy in tip length may impact clinical placement accuracy.

The affected units were distributed worldwide, including nationwide distribution in the United States to numerous states and the District of Columbia, as well as to various international countries. Healthcare providers and facilities that have received these specific lot numbers should stop using the devices and contact the manufacturer for further instructions.

The recalled product

Product: Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, 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: 169

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 (3)

UDI: 00816203022103
Lot: N18431
N18431-1

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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Same hazard · manufacturing defect