FDA Medical Device Recalls (openFDA)
Nellcor Puritan Bennett Inc. (dba Covidien Ltd): Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, 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.
- Recall number
- Z-1499-2010
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
- Product
- Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, 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.
- Status
- Terminated
- Initiated
- 2010-04-13
- Posted
- 2010-05-06
- Terminated
- 2012-01-18
- 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
- 1741 units
- Distribution
- Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.
- Lot, serial or model codes
- Lot Numbers: 0903000867 through 0907001525
- 510(k) numbers
- ["K955680"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28