Class 3 Device Recall FIRMap 60mm Catheter

• Date Initiated by Firm: August 12, 2015
• Date Posted: August 28, 2015
• Recall Status: Terminated on September 23, 2015
• Recall Number: Z-2478-2015
• Recall Event ID: 71970
• 510(K)Number: K130827
• Product Classification: Catheter,intracardiac mapping,high-density array - Product Code MTD
• Product: FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
• Code Information: Model number : USAR064060; Lot code: TPR031615-01
• Recalling Firm/ Manufacturer: Abbott Electrophysiology; 1530 Obrien Dr; Menlo Park CA 94025-1454
• For Additional Information Contact: Ken Perino; 650-681-1744
• Manufacturer Reason for Recall: The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.
• FDA Determined Cause: Incorrect or no expiration date
• Action: The firm, Abbott Electrophysiology, sent an "URGENT PRODUCT RECALL" letter dated August 11, 2015. A customer recall notification letter was distributed to firm representatives who will visit each consignee and inspect inventory for affected product. Letters were provided to reps on August 12, 2015. The letter describes the product, problem and actions to be taken. The customers were informed that the product they have in stock will be return to the firm and will be provided a replacement product free of charge. If you have any questions, contact Quality Director at 650-681-1744.
• Quantity in Commerce: 86 units
• Distribution: US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.
• 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 = MTD