Class 2 Device Recall Cardioplegia Delivery System

• Date Initiated by Firm: May 09, 2003
• Date Posted: July 02, 2003
• Recall Status: Terminated on July 08, 2003
• Recall Number: Z-0960-03
• Recall Event ID: 26361
• 510(K)Number: K934847
• Product Classification: Reservoir, Blood, Cardiopulmonary Bypass - Product Code DTN
• Product: Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
• Code Information: Catalog # 027819201, Lot Number 0304300106.
• Recalling Firm/ Manufacturer: Cobe Cardiovascular, Inc; 14401 West 65th Way; Arvada CO 80004
• For Additional Information Contact: 303-425-5508
• Manufacturer Reason for Recall: Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
• FDA Determined Cause: Other
• Action: All consignees were contacted by telephone on 05/09/2003, followed by a letter.
• Quantity in Commerce: 60 units
• Distribution: MN, NE, OK
• 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