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U.S. Department of Health and Human Services

Enforcement Report - Week of October 24, 2012

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Event Detail

Event ID 63225
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-10-02
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. No lot/serial number; Catalog number: PN 816280 Class II 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 ½ inch connector supports instead of one 3/8 inch and two ½ inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions and drawings; however, the drawings were incorrect. The incorrect configuration was identified by company. Replacement support connectors were provided to customers that had been shipped the devices and all other units in inventory were corrected. The affected units were manufactured and distributed between January 2008 and May 2009. A notification of this correction was not reported to FDA at that time. 33 units Z-0071-2013