Class 2 Device Recall

• Date Initiated by Firm: May 25, 2005
• Date Posted: July 28, 2005
• Recall Status: Terminated on December 02, 2005
• Recall Number: Z-1057-05
• Recall Event ID: 32165
• 510(K)Number: K980987
• Product Classification: Syringe, Piston - Product Code FMF
• Product: #309644 -- 10 ml syringe with 20 G1'' Needle
• Code Information: 309644 10 ml Syringe with 20 G1'' Needle 5033890
• 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: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
• FDA Determined Cause: Other
• Action: BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
• Quantity in Commerce: 1200 units
• Distribution: BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
• 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