Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

REF VV19F Reinforced Dual Lumen Cannula Recalled by OriGen Biomedical, Inc. Due to Potential for clear extension tube to separate from...

Date: March 30, 2015
Company: OriGen Biomedical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OriGen Biomedical, Inc. directly.

Affected Products

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.

Quantity: 134

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OriGen Biomedical, Inc.

OriGen Biomedical, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report