medical Class II Updated 2018-10-24

OriGen Biomedical, Inc. recalls Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

Recalled 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.


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: 00816203022059, Lot: N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, N18573
View official government recall

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