Class 2 Device Recall

• Date Initiated by Firm: July 07, 2004
• Date Posted: August 17, 2004
• Recall Status: Terminated on October 26, 2004
• Recall Number: Z-1358-04
• Recall Event ID: 29475
• 510(K)Number: K915193A
• Product Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
• Product: Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire stylet, ribbed balloon; catalog number 7272.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: Brian L. Dawson; 800-262-7866 Ext. 6066
• Manufacturer Reason for Recall: The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
• FDA Determined Cause: Other
• Action: The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.
• Distribution: United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.
• 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.