Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the...
FDA Recall #Z-0071-2013 — Class II — October 2, 2009
Product Description
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 for Recall
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 — Ann Arbor, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
33 units
Distribution
Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.
Code Information
No lot/serial number; Catalog number: PN 816280
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated