Recall Z-2871-2017— Sorin Group USA, Inc.

Name: FDA recall Z-2871-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-09

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2017-06-09, terminated 2023-11-09. It names one FDA 510(k) clearance: K943934. Product: Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.. Reason: Identification of excess plastic on the tip of the cannula..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-09
Terminated: 2023-11-09
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

Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

Reason for recall

Identification of excess plastic on the tip of the cannula.

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