medical Class II Updated 2018-10-24

OriGen Biomedical, Inc. recalls ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Steri

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00816203022124, Lot: N18487, N18487-1, N18561-1, R19169
View official government recall

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