Recall Z-2106-2014— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-2106-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-23

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2014-05-23, terminated 2015-02-24. It names 2 FDA 510(k) clearances: K905224, K790246. Product: CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.. Reason: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications.

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-05-23
Terminated: 2015-02-24
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

2 on FDA's record

K905224 — CARDIOPULMONARY BYPASS VASCULAR CATHETER3M Health Care, Sarns·cleared 1991-02-05
K790246 — SARNS WIRE-REINFORCED VENOUS RETURN CAN3M Health Care, Sarns·cleared 1979-03-02

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

CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.

Reason for recall

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

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