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U.S. Department of Health and Human Services

Class 3 Device Recall Portex

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  Class 3 Device Recall Portex see related information
Date Initiated by Firm May 05, 2005
Date Posted June 01, 2005
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0858-05
Recall Event ID 32076
510(K)Number K923127   
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1''
Catalog Number: 4238
Code Information Lot Number: K621494
Recalling Firm/
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact Timothy Talcott
603-352-3812 Ext. 2457
Manufacturer Reason
for Recall
Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"
FDA Determined
Cause 2
Action Smith Medical notified dealers of the recall on May 5, 2005 by telephone. The remaining customers were notified on May 12, 2005 by telephone. Follow-up letter delivered by Federal Express on May 17, 2005.
Quantity in Commerce 159 cases (400 per case) =63,600 each.
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.