Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Dual Stage Venous Return Catheter Recalled by Sorin Group USA, Inc. Due to Sorin Group initiated field correction for the Dual...

Date: January 25, 2016
Company: Sorin Group USA, 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 Sorin Group USA, Inc. directly.

Affected Products

Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.

Quantity: 60

Why Was This Recalled?

Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Sorin Group USA, Inc.

Sorin Group USA, Inc. has 52 total recalls tracked by RecallDetector.

Related Recalls

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