Class 2 Device Recall

• Date Initiated by Firm: June 29, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-1078-04
• Recall Event ID: 29498
• 510(K)Number: K011925
• Product Classification: Needle, Hypodermic, Single Lumen - Product Code FMI
• Product: Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
• Code Information: Lot Number: K527299
• FEI Number: 1217052
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 10 Bowman Dr; Keene NH 03431-5043
• For Additional Information Contact: Brian Farias; 603-352-3812
• Manufacturer Reason for Recall: Sterility of product is not assured
• FDA Determined Cause: Other
• Action: Smiths Medical notified consignees by telephone on June 29, 2004. The consignees were asked to immediately quarantine their stock . The Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004.
• Quantity in Commerce: 180 CASES (400/CS)
• Distribution: Nationwide
• 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 = FMI