Class 2 Device Recall

• Date Initiated by Firm: September 05, 2002
• Date Posted: January 14, 2003
• Recall Status: Terminated on December 03, 2003
• Recall Number: Z-0444-03
• Recall Event ID: 25313
• 510(K)Number: K013801
• Product Classification: Syringe, Antistick - Product Code MEG
• Product: UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
• Code Information: Lot T20201501
• Recalling Firm/ Manufacturer: Safety Syringes Inc; 1939 Palomar Oaks Way #A; Carlsbad CA 92009
• For Additional Information Contact: Thomas L. Hall; 760-918-9908
• Manufacturer Reason for Recall: Package integrity not validated. Sterility not assured.
• FDA Determined Cause: Other
• Action: Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.
• Quantity in Commerce: 3300
• Distribution: Medical offices located in California.
• 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 = MEG and Original Applicant = SAFETY SYRINGES, INC.