Class 2 Device Recall Cardiovascular Procedure Kit

• Date Initiated by Firm: May 12, 2017
• Create Date: July 26, 2018
• Recall Status: Terminated on October 26, 2018
• Recall Number: Z-2550-2018
• Recall Event ID: 80283
• Product Classification: Cardiovascular procedure kit - Product Code OEZ
• Product: Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
• Code Information: Lot Number: VE17
• FEI Number: 1000149028
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 28 Howe St; Ashland MA 01721-1305
• For Additional Information Contact: Garry A. Courtney, MBA, RAC; 800-262-3304
• Manufacturer Reason for Recall: Kit was labeled with the incorrect Expiration Date of April 30, 2019.
• FDA Determined Cause: Incorrect or no expiration date
• Action: On May 12, 2017 Terumo Cardiovascular Systems Corporation telephoned their one client and notified them of the labeling error and asked them to hold product. All product was immediately quarantined.
• Quantity in Commerce: 30 cases/2 units (Total 60 units)
• Distribution: US state of FL
• 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.