Recall Z-0813-2016— Sorin Group USA, Inc.

Name: FDA recall Z-0813-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-25

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2016-01-25, terminated 2016-10-24. It names one FDA 510(k) clearance: K943934. Product: 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.. Reason: Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-25
Terminated: 2016-10-24
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K943934 — AORTIC ARCH CANNULASSorin Group Italia S.R.L.·cleared 1995-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.