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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 05, 2002
Date Posted January 14, 2003
Recall Status1 Terminated 3 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/
Safety Syringes Inc
1939 Palomar Oaks Way #A
Carlsbad CA 92009
For Additional Information Contact Thomas L. Hall
Manufacturer Reason
for Recall
Package integrity not validated. Sterility not assured.
FDA Determined
Cause 2
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.