Class 2 Device Recall ReliOn

• Date Initiated by Firm: June 21, 2007
• Date Posted: September 20, 2007
• Recall Status: Terminated on June 03, 2008
• Recall Number: Z-1226-2007
• Recall Event ID: 38399
• 510(K)Number: K024112
• Product Classification: syringe - Product Code FMI
• Product: ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe; 30 gauge x 5/16" length, for subcutaneous injection of insulin.
• Code Information: Catalog number 326743, Batch number 6297350
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Wafa Al-Rimawi; 201-847-6795
• Manufacturer Reason for Recall: Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.
• FDA Determined Cause: Other
• Action: Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.
• Quantity in Commerce: 644,500 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.

• 510(K) Database: 510(K)s with Product Code = FMI and Original Applicant = BECTON DICKINSON & CO.