OriGen Biomedical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1456-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: March 30, 2015

Date Posted: April 29, 2015

Recall Number: Z-1456-2015

Event ID: 70988

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: 51 units

Code Information:

Lot N18549

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated