Recall Z-2147-2016— Sorin Group USA, Inc.

Name: FDA recall Z-2147-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-22

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2016-06-22, terminated 2017-03-27. It names one FDA 510(k) clearance: K943934. Product: AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.. Reason: Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-22
Terminated: 2017-03-27
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

AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

Reason for recall

Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.

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