Sorin Group USA, Inc. recalls Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration…

Recall date

January 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0813-2016

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

US Distribution to CA., and Internationally to Canada.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.