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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Backplate Replacement CXFVR 1500 Holder

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  Class 2 Device Recall Terumo Backplate Replacement CXFVR 1500 Holder see related information
Date Initiated by Firm October 02, 2009
Date Posted October 16, 2012
Recall Status1 Terminated 3 on January 29, 2013
Recall Number Z-0071-2013
Recall Event ID 63225
Product Classification Accessory equipment, cardiopulmonary bypass - Product Code KRI
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.
Code Information No lot/serial number; Catalog number: PN 816280
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
Manufacturer 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
FDA Determined
Cause 2
Labeling design
Action 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.
Quantity in Commerce 33 units
Distribution Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.