Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Ben
FDA device recall Z-1512-2010 · posted 2010-05-06 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
- Reason for recall
- Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
- Action taken
- 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
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 1 unit
- Distribution
- Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.
- Date initiated
- 2010-04-13
- Date posted
- 2010-05-06
- Date terminated
- 2012-01-18
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE (K925615) | Sorin Biomedica, Fiat, USA, Inc. | 1993-03-26 |