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U.S. Department of Health and Human Services

Class 1 Device Recall Cook Medical Ciaglia Blue Dolphin

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  Class 1 Device Recall Cook Medical Ciaglia Blue Dolphin see related information
Date Initiated by Firm April 21, 2010
Date Posted July 26, 2010
Recall Status1 Terminated 3 on January 23, 2012
Recall Number Z-2076-2010
Recall Event ID 56084
510(K)Number K093469  
Product Classification Percutaneous Tracheostomy Introducer Set - Product Code JOH
Product Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.
Code Information 2353818, 2240387, 2283507, 2391559, 2272941, 2395596, 2277074, 2395598, 2251489, 2300211, 2277076, 2300213, 2304560, 2314057, 2272101, 2314055, 2330811, 2297629, 2353821, 2260715, 2255291, 2272942, 2283506, 2353819, 2395597, 2240386, 2277075, 2251488, 2254635, 2246873, 2435157, 2304561, 2314056, 2314056, 2283508, 2330810, 2297628, 2280908, 2260714, 2353820, 2413134, 2442415, 2444002, 2442416, and 2444001.
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
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
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 = COOK, INC.
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