—#113066

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.

FDA product code: KRI — Accessory Equipment, Cardiopulmonary Bypass
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: No lot/serial number; Catalog number: PN 816280

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

The firm, Terumo, interviewed the Sr. Product Manager from the Marketing Department of the company on August 29, 2012. The interview included the description of the product, problem and action taken. Replacement connectors were provided to users and all units were corrected. If you have any questions, call 734-663-4145 or Manager, Regulatory Affairs at 734-741-5576.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.

Timeline

Recall initiated: 2009-10-02
Posted by FDA: 2012-10-16
Terminated: 2013-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113066. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.