Class 2 Device Recall Cardiovascular Procedure KitTerumo Cardiovascular Systems Corporation

• Date Initiated by Firm: June 08, 2010
• Date Posted: September 29, 2010
• Recall Status: Terminated on February 29, 2012
• Recall Number: Z-2615-2010
• Recall Event ID: 56413
• 510(K)Number: K900640
• Product Classification: Cardiovascular Procedure Kits - Product Code DTR
• Product: Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03
• Code Information: Lot numbers: MD15, and MD26
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Corporation; 125 Blue Ball Road; Elkton MD 21921-5315
• For Additional Information Contact: Mike Silvestri; 410-392-7102
• Manufacturer Reason for Recall: Medical device vent port may be occluded and prevent delivery of priming fluid.
• FDA Determined Cause: Equipment maintenance
• Action: Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.
• Quantity in Commerce: 110 kits
• Distribution: The products were distributed 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 = DTR