| Class 1 Device Recall Shiley Cuffed Pediatric Tracheostomy Tube | |
Date Initiated by Firm | April 13, 2010 |
Date Posted | May 06, 2010 |
Recall Status1 |
Terminated 3 on January 18, 2012 |
Recall Number | Z-1493-2010 |
Recall Event ID |
55354 |
510(K)Number | K955680 |
Product Classification |
Tube tracheostomy and tube cuff - Product Code JOH
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Product | Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled 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: 0903000861 through 0908000693 |
Recalling Firm/ Manufacturer |
Nellcor Puritan Bennett Inc. (dba Covidien Ltd) 6135 Gunbarrel Ave Boulder CO 80301-3214
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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 | 4,435 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 |
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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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