Class 2 Device Recall PortACath Tray

• Date Initiated by Firm: June 12, 2014
• Date Posted: July 01, 2014
• Recall Status: Terminated on February 03, 2015
• Recall Number: Z-1953-2014
• Recall Event ID: 68564
• Product Classification: Suture kit - Product Code OVN
• Product: Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
• Code Information: Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015.
• Recalling Firm/ Manufacturer: Medical Action Industries Inc; 25 Heywood Rd; Arden NC 28704-9302
• For Additional Information Contact: Larry D. Bogues; 757-566-3510 Ext. 9315
• Manufacturer Reason for Recall: Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.
• Quantity in Commerce: 474 cs (9,480 ea) total for all kits involved
• Distribution: Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
• 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.