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Recall Observatory FDA recall evidence

Device product

REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.

Z-0269-2019

March 30, 2015

Class I

Product summary

Firm
OriGen Biomedical, Inc.
Event
Event 81164
Status
Terminated
Classification
Class I
Quantity
134
Official record key
device-enforcement:Z-0269-2019

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: Product Code UDI Lot VV19F 00816203022097 N18394

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom

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