Class 2 Device Recall Portex

• Date Initiated by Firm: July 02, 2004
• Date Posted: July 30, 2004
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-1260-04
• Recall Event ID: 29490
• Product Classification: Anesthesia Conduction Kit - Product Code CAZ
• Product: 15816-21 SPINAL(DD) 27G QUINCKE W/DRUGS
• Code Information: Lot Number: K516574
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 10 Bowman Dr; Keene NH 03431-5043
• Manufacturer Reason for Recall: Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product.
• FDA Determined Cause: Other
• Action: Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter
• Quantity in Commerce: 120 units
• 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.