Recall Z-0071-2013— Terumo Cardiovascular Systems Corporation

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2009-10-02, terminated 2013-01-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.. Reason: Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a.

Recalling firm

Terumo Cardiovascular Systems Corporation

Classification

Class II

Status

Terminated

Initiated

2009-10-02

Terminated

2013-01-29

Firm location

Ann Arbor, MI, United States

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