Date Initiated by Firm |
September 18, 2007 |
Date Posted |
November 07, 2007 |
Recall Status1 |
Terminated 3 on May 08, 2012 |
Recall Number |
Z-0100-2008 |
Recall Event ID |
44792 |
510(K)Number |
K031057
|
Product Classification |
Tracheostomy Tube - Product Code JOH
|
Product |
Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
|
Code Information |
Lot Number: 1155185 |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 10 Bowman Dr Keene NH 03431-5043
|
For Additional Information Contact |
SAME 603-352-3812
|
Manufacturer Reason for Recall |
Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
|
FDA Determined Cause 2 |
Process control |
Action |
Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical. |
Quantity in Commerce |
40 units |
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.
|
510(K) Database |
510(K)s with Product Code = JOH and Original Applicant = PORTEX, INC.
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