Class 2 Device Recall VCATH Insertion Kits

• Date Initiated by Firm: April 05, 2011
• Date Posted: May 19, 2011
• Recall Status: Terminated on November 22, 2011
• Recall Number: Z-2223-2011
• Recall Event ID: 58514
• Product Classification: I.V. Start Kit - Product Code LRS
• Product: V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
• Code Information: Lot # Expiration Date 2009092850 5/31/2011 2010012950 5/31/2011 2010030150 8/31/2011 2010043050 8/31 2011 2010061850 12/31/2011 2010062950 12/31/2011 2010082650 12/31/2011
• Recalling Firm/ Manufacturer: Neo Medical, Inc.; 42514 Albrae St.; Fremont CA 94538
• For Additional Information Contact: Pamala Duvall; 888-450-3334 Ext. 100
• Manufacturer Reason for Recall: Firm received recall notice from their contract manufacturer due to visible particulates in Bacteriostatic Sodium Chloride Injection, USP 0.9%, 30 mL vials that are included in insertion kits.
• FDA Determined Cause: Material/Component Contamination
• Action: Neo Medical forwarded Urgent Recall Notices to Dealers and customers on April 5, 2011 via fax. Neo Medical Customer Care also contacted customers by phone on April 7, 2011, followed by Urgent Product Recall Notification letters were sent on April 11, 2011 along with a copy of the Recall Notification from Centurion. The letter requested that customers with affected lots immediately discontinue distribution and contact the end users instructing them to stop dispensing the product. Customers were to complete the accountability information even if inventory had been depleted and fax it to 510-353-9025. In order to return the affected product, customers should contact the Complaint Coordinator at 925-719-2197 or pjduvall@neomedicalinc.com. Replacement or credit would be issued for all product returned.
• Quantity in Commerce: 1990
• Distribution: Worldwide Distribution -- USA, including states of MO, WA, PA, CA, OH, UT, TX and Canada.
• 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.