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Recall Observatory FDA recall evidence

Device product

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.

Z-1456-2015

March 30, 2015

Class I

Product summary

Firm
OriGen Biomedical, Inc.
Event
Event 70988
Status
Terminated
Classification
Class I
Quantity
51 units
Official record key
device-enforcement:Z-1456-2015

Official wording

Reason: 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.

Code information: Lot N18549

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.