Recall Z-1517-2010 ยท JOH Tube Tracheostomy And Tube Cuff
Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M8FEN, 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.
| Date | May 6, 2010 (initiated Apr 13, 2010) |
| Status | Terminated |
| Reason | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Root cause | 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 | 20 units |
| Distribution | Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903435 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE Shiley, Inc., Oct 2, 1990 |