OriGen Biomedical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0269-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: March 30, 2015

Date Posted: November 14, 2018

Recall Number: Z-0269-2019

Event ID: 81164

Reason for Recall:

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

Status: Terminated

Product Quantity: 134

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

Voluntary or Mandated:

Voluntary: Firm initiated