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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 May 16, 2005
Date Posted June 04, 2005
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0869-05
Recall Event ID 32079
510(K)Number K031057  
Product Classification Tube Tracheostomy And Tube Cuff - Product Code JOH
Product Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm
Product Number: 535090
Code Information Lot Numbers: K515076, K518078, K558496, K586109, K614402, K629274
Recalling Firm/
Manufacturer		 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		 Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
FDA Determined
Cause 2		 Other
Action Smith Medical ASD initiated recall by letter on/about about May 16, 2005.
Distribution Natiowide Foreign: Canada, Mexico and East Timor.
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 = JOH and Original Applicant = PORTEX, INC.
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