Date Initiated by Firm | May 16, 2005 |
Date Posted | June 04, 2005 |
Recall Status1 |
Terminated 3 on May 08, 2012 |
Recall Number | Z-0870-05 |
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 7.0mm
Product Number: 538070E |
Code Information |
Lot Number: K510891 |
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.
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510(K) Database | 510(K)s with Product Code = JOH
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