| Class 1 Device Recall Cook Medical Ciaglia Blue Dolphin | |
Date Initiated by Firm | April 21, 2010 |
Date Posted | July 26, 2010 |
Recall Status1 |
Terminated 3 on January 23, 2012 |
Recall Number | Z-2092-2010 |
Recall Event ID |
56084 |
510(K)Number | K093469 |
Product Classification |
Percutaneous Tracheostomy Introducer Set - Product Code JOH
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Product | Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51972, C-PTBSYJC-2800-PERC8. |
Code Information |
2323340 |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact | 812-339-2235 |
Manufacturer Reason for Recall | These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately. |
Quantity in Commerce | 28819 total, all products |
Distribution | Worldwide distribution: USA, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay. |
Total Product Life Cycle | TPLC Device Report |
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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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