Class 2 Device Recall Cardioplegia Delivery Set

• Date Initiated by Firm: May 25, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on March 31, 2005
• Recall Number: Z-1009-04
• Recall Event ID: 29261
• 510(K)Number: K934847
• Product Classification: Reservoir, Blood, Cardiopulmonary Bypass - Product Code DTN
• Product: Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
• Code Information: Catalog # 027770201, Lot # 0406800015.
• Recalling Firm/ Manufacturer: Cobe Cardiovascular, Inc; 14401 W 65th Way; Arvada CO 80004-3524
• For Additional Information Contact: 303-425-5508
• Manufacturer Reason for Recall: Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
• FDA Determined Cause: Other
• Action: Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.
• Quantity in Commerce: 216 sets
• Distribution: AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.
• 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 = DTN and Original Applicant = SORIN BIOMEDICAL, INC.