Class 3 Device Recall Portex

• Date Initiated by Firm: October 27, 2006
• Date Posted: November 22, 2006
• Recall Status: Terminated on May 22, 2012
• Recall Number: Z-0211-2007
• Recall Event ID: 36643
• 510(K)Number: K965017
• Product Classification: epidural anesthesia tray - Product Code CAZ
• Product: Portex Continuous Epidural tray ; Ref 4948-17
• Code Information: Lot Number: 1063342
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 10 Bowman Dr; Keene NH 03431-5043
• For Additional Information Contact: Timothy J. Talcott; 603-352-3812 Ext. 2457
• Manufacturer Reason for Recall: Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch
• FDA Determined Cause: Other
• Action: Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.
• Quantity in Commerce: 540 units
• Distribution: Nationwide and Panama
• 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 = CAZ and Original Applicant = SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.