Class 2 Device Recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Cat

• Date Initiated by Firm: June 07, 2010
• Date Posted: August 25, 2010
• Recall Status: Terminated on September 29, 2012
• Recall Number: Z-2274-2010
• Recall Event ID: 55933
• 510(K)Number: K781846
• Product Classification: introducer - Product Code KGZ
• Product: Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
• Code Information: Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
• FEI Number: 3015859709
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Road; Reading PA 19605
• For Additional Information Contact: 610-378-0131
• Manufacturer Reason for Recall: Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.
• FDA Determined Cause: Process change control
• Action: June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.
• Quantity in Commerce: 3000 kits
• Distribution: All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
• 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 = KGZ