Class 2 Device Recall Softflow

• Date Initiated by Firm: October 19, 2005
• Date Posted: November 23, 2005
• Recall Status: Terminated on March 10, 2006
• Recall Number: Z-0181-06
• Recall Event ID: 33955
• 510(K)Number: K934127
• Product Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
• Product: Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080.
• Code Information: All lots (0332197, 0349597, 0360492, 0369078, 0373045, 0382401, 0391806 and 0399838).
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: Brian Dawson; 800-262-3304 Ext. 6066
• Manufacturer Reason for Recall: The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
• FDA Determined Cause: Other
• Action: Consignees were notified via telephone, and a recall letter dated 10/19/05 sent to each consignee, beginning on 10/18/05. International affiliates were notified via email.
• Quantity in Commerce: 48
• Distribution: California, Indiana, Missouri, Brazil and Germany.
• 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.

• 510(K) Database: 510(K)s with Product Code = DWF