Class 2 Device Recall Portex Spinal

• Date Initiated by Firm: October 10, 2003
• Date Posted: November 27, 2003
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-0166-04
• Recall Event ID: 27470
• 510(K)Number: K965017
• Product Classification: Anesthesia Conduction Kit - Product Code CAZ
• Product: Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
• Code Information: Lot number: K203631 Exp. Date: 2004-08
• Recalling Firm/ Manufacturer: Portex Inc; 10 Bowman Dr; Keene NH 03431-5043
• For Additional Information Contact: Timothy J. Talcott; 603-352-3812 Ext. 2457
• Manufacturer Reason for Recall: Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.
• FDA Determined Cause: Other
• Action: Portex notified consignees on 10/10/03 by letter issued by Federal Express. Distributors were asked to supply customer list to Portex or to notify their accounts with copy of the recall letter provided.
• Quantity in Commerce: 2600 units
• 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