Agency classClass IIOur severity:High FDA (Devices)·Z-0184-2019·Announced 2018-10-24

OriGen Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

OriGen Biomedical is recalling 73 units of 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 in extracorporeal life support with manufacturing deficiencies (missing radiopaque material and incorrect dimensions) that pose a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

OriGen Biomedical, Inc. is recalling 73 units of the Reinforced Dual Lumen Cannula, 32Fr. (REF: VV32F, Sterile EO). The recall affects units with UDI 00816203022148 and Lot P18806. 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 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 length discrepancy may impact clinical usage.

The affected units were distributed nationwide in the United States to 33 states and the District of Columbia, as well as to 22 countries worldwide. Healthcare providers and facilities that have received these specific units should stop using them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, 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 — Catheters
Hazard: manufacturing-defect
mis-labeling
Affected units: 73

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 (2)

UDI: 00816203022148
Lot: P18806

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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