Z-1512-2010

Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor...

Name: Z-1512-2010 Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor...
Creator: Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Published: 2010-04-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-04-13 / Terminated / root cause: manufacturing process

FDA source

Nellcor Puritan Bennett Inc. (dba Covidien Ltd) began a recall of Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended... on 2010-04-13. The reason FDA records is "Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1512-2010
Status: Terminated
Initiated: 2010-04-13
Posted: 2010-05-06
Terminated: 2012-01-18
Recalling firm: Medtronic, Inc.
Product: Shiley Specialized Tracheostomy Tube, M5.5PDC, 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.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Number: 0905000552

Product code JOH

K925615Class IIShiley Specialized,pediatric & Neonatal Trach.tubeSorin Biomedica, Fiat, USA, Inc. / cleared 1993-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)