Class 3 Device Recall ReliOn

• Date Initiated by Firm: October 22, 2004
• Date Posted: March 03, 2005
• Recall Status: Terminated on April 14, 2006
• Recall Number: Z-0569-05
• Recall Event ID: 30390
• 510(K)Number: K955235
• Product Classification: Syringe, Piston - Product Code FMF
• Product: ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.
• Code Information: Batch # 4083690
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Greg Morgan; 201-847-4344
• Manufacturer Reason for Recall: Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).
• FDA Determined Cause: Other
• Action: BD has sent letters to the distributor McKesson Inc and the retailer Wal-Mart Inc.
• Quantity in Commerce: 1543000 syringes
• Distribution: The syringes were sent to McKesson Corp, 120 Senlac Drive, Carrollton, TX 75006 who then sold them to Wal-Mart Corp, 702 SW 8th Street, Bentonville, AR 72716. There are no other customers.
• 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 = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC