Class 2 Device Recall Polysulfone Petite Vital Port

• Date Initiated by Firm: April 24, 2008
• Date Posted: September 17, 2008
• Recall Status: Terminated on September 18, 2008
• Recall Number: Z-2190-2008
• Recall Event ID: 48642
• 510(K)Number: K924748
• Product Classification: Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
• Product: Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter
• Code Information: Catalog number IP-S5118-N. Lot number N73127
• Recalling Firm/ Manufacturer: Cook Vascular Inc.; 1186 Montgomery Ln; Vandergrift PA 15690-6065
• For Additional Information Contact: Thomas Kardos; 724-845-8621 Ext. 2225
• Manufacturer Reason for Recall: Mislabeled - wrong size catheter was packaged in the box
• FDA Determined Cause: Packaging process control
• Action: The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.
• Quantity in Commerce: 21 units
• Distribution: The products were shipped to distributors in Japan and Brazil.
• 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 = LJT