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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 October 27, 2006
Date Posted November 22, 2006
Recall Status1 Terminated 3 on May 22, 2012
Recall Number Z-0211-2007
Recall Event ID 36643
510(K)Number K965017  
Product Classification epidural anesthesia tray - Product Code CAZ
Product Portex Continuous Epidural tray
Ref 4948-17
Code Information Lot Number: 1063342
Recalling Firm/
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact Timothy J. Talcott
603-352-3812 Ext. 2457
Manufacturer Reason
for Recall
Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch
FDA Determined
Cause 2
Action Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.
Quantity in Commerce 540 units
Distribution Nationwide and Panama
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 = CAZ and Original Applicant = SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.