Class 2 Device Recall Terumo TenderFlow Pediatric Arterial Cannulae

• Date Initiated by Firm: May 22, 2007
• Date Posted: July 10, 2007
• Recall Status: Terminated on July 07, 2009
• Recall Number: Z-0877-2007
• Recall Event ID: 37996
• 510(K)Number: K063618
• Product Classification: Arterial Cannulae - Product Code DWF
• Product: Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570.
• Code Information: Lot 2120265.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
• FDA Determined Cause: Other
• Action: Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.
• Quantity in Commerce: 100
• Distribution: Nationwide.
• 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