Class 2 Device Recall Sarns arterial cannula

• Date Initiated by Firm: September 12, 2005
• Date Posted: November 26, 2005
• Recall Status: Terminated on March 22, 2006
• Recall Number: Z-0200-06
• Recall Event ID: 33506
• 510(K)Number: K771499
• Product Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
• Product: Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.
• Code Information: Lots 0385384 and 0386969.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-262-3304 Ext. 6066
• Manufacturer Reason for Recall: There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.
• FDA Determined Cause: Other
• Action: Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05.
• Quantity in Commerce: 2520
• Distribution: Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.
• 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