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U.S. Department of Health and Human Services

Class 2 Device Recall Portex

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 Class 2 Device Recall Portexsee related information
Date Initiated by FirmSeptember 09, 2004
Date PostedNovember 24, 2004
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-0253-05
Recall Event ID 29990
510(K)NumberK952516 
Product Classification Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
ProductPortex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1615
Code Information Lot numbers starting with: 1, K1, K2, K51 
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information ContactTimothy J. Talcott
603-352-3812 Ext. 2667
Manufacturer Reason
for Recall
Sterility of the device is compromised due to packaging defects
FDA Determined
Cause 2
Other
ActionSmiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JKA
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