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U.S. Department of Health and Human Services

Class 1 Device Recall Shiley Specialized Tracheostomy Tube

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  Class 1 Device Recall Shiley Specialized Tracheostomy Tube see related information
Date Initiated by Firm April 13, 2010
Date Posted May 06, 2010
Recall Status1 Terminated 3 on January 18, 2012
Recall Number Z-1507-2010
Recall Event ID 55354
510(K)Number K903435  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product Shiley Specialized Tracheostomy Tube, M8SCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA.

Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.
Code Information Lot Numbers: 0904000132 through 0910001376
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact
303-305-2382
Manufacturer Reason
for Recall		 Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
FDA Determined
Cause 2		 Process design
Action Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm. For further Information, contact Covidien at 1-800-635-5267.
Quantity in Commerce 198 units
Distribution Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore 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 = SHILEY, INC.
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