Class 2 Device Recall Arrow Internationa IABP

• Date Initiated by Firm: November 27, 2012
• Date Posted: April 06, 2013
• Recall Status: Terminated on June 02, 2015
• Recall Number: Z-1064-2013
• Recall Event ID: 64527
• 510(K)Number: K000729 K021462
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.
• Code Information: Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Road; Reading PA 19605
• For Additional Information Contact: Jennifer Thompson; 610-378-0131 Ext. 3474
• Manufacturer Reason for Recall: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
• FDA Determined Cause: Process control
• Action: Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.
• Quantity in Commerce: 188 units
• Distribution: Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.
• 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 = DSP