OriGen Biomedical, Inc. recalls OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomed…

Recall date

March 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1456-2015

FDA classification

Class I

Brand / firm

OriGen Biomedical, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.

Why it was recalled

Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter 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 of six hours or less.