Class 2 Device Recall 9 French Super ArrowFlex Percutaneous Sheath Introducer Kit

• Date Initiated by Firm: July 08, 2003
• Date Posted: July 19, 2003
• Recall Status: Terminated on September 02, 2004
• Recall Number: Z-1035-03
• Recall Event ID: 26680
• 510(K)Number: K940079
• Product: 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
• Code Information: Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605
• For Additional Information Contact: Thomas D. Nickel; 610-478-3137
• Manufacturer Reason for Recall: separation of sheath
• FDA Determined Cause: Other
• Action: The recalling firm issued recall letters dated 7/9/03 to their accounts informing them of the problem and the need to return the product. To expedite product removal the recalling firm telephoned the accounts that received the complaint lot.
• Quantity in Commerce: 13442 units
• Distribution: The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Netherlands, SPain, and Greece.

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 = and Original Applicant = ARROW INTL., INC.