Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, 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.
FDA Recall Z-1471-2010 · Posted 2010-05-06
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Recalling FirmNellcor Puritan Bennett Inc. (dba Covidien Ltd)
Recall StatusTerminated
Product CodeJOH
Date Initiated2010-04-13
Date Terminated2012-01-18
Product Quantity14,419 units
Reason for Recall
Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Firm 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.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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