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U.S. Department of Health and Human Services

Class 2 Device Recall VCATH Insertion Kits

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  Class 2 Device Recall VCATH Insertion Kits see related information
Date Initiated by Firm April 05, 2011
Date Posted May 19, 2011
Recall Status1 Terminated 3 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 2
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.
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