OriGen Biomedical, Inc.: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip

Agency Publication Date: October 18, 2018

Affected Products

Product: Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, 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 procedures.

UDI: 00816203022059, Lot: N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, N18573

Lot Numbers:

N18687

Product: Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, 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 procedures.

UDI 00816203022073, Lot: N18404, N18446, N18640, N18640-1, R19208

Lot Numbers:

N18404

Product: Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, 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 procedures.

UDI: 00816203022097, Lot: N18394, N18447, N18447-1, N18447-1A, P18909, P18971

Lot Numbers:

N18394

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 procedures.

UDI: 00816203022103, Lot: N18431, N18431-1

Lot Numbers:

N18431

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 procedures.

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

Lot Numbers:

N18487

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 procedures.

UDI: 00816203022148, Lot: P18806

Lot Numbers:

P18806

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80930

Status: Resolved

Manufacturer: OriGen Biomedical, Inc.

Manufactured In: United States

Units Affected: 6 products (1517; 452; 435; 169; 241; 73)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

UDI: 00816203022059, Lot: N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, N18573

Lot Numbers:

N18687

UDI 00816203022073, Lot: N18404, N18446, N18640, N18640-1, R19208

Lot Numbers:

N18404

UDI: 00816203022097, Lot: N18394, N18447, N18447-1, N18447-1A, P18909, P18971

Lot Numbers:

N18394

UDI: 00816203022103, Lot: N18431, N18431-1

Lot Numbers:

N18431

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

Lot Numbers:

N18487

UDI: 00816203022148, Lot: P18806

Lot Numbers:

P18806