Z-1312-04

Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal...

Name: Z-1312-04 Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal...
Creator: Nellcor Puritan Bennett
Published: 2004-07-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-07-08 / Terminated

FDA source

Nellcor Puritan Bennett began a recall of Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal Extension, Uncuffed; 72110-060, size 6, Proximal... on 2004-07-08. The reason FDA records is "Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1312-04
Status: Terminated
Initiated: 2004-07-08
Posted: 2004-08-07
Terminated: 2005-11-29
Recalling firm: Medtronic, Inc.
Product: Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal Extension, Uncuffed; 72110-060, size 6, Proximal Extension, Uncuffed; 72110-070, size 7, Proximal Extension, Uncuffed; 72110-080, size 8, Proximal Extension, Uncuffed; 72120-050, size 5, Promixal Extension, Cuffed; 72120-060, size 6, Promixal Extension, Cuffed; 72120-070, size 7, Promixal Extension, Cuffed; 72120-080, size 8, Promixal Extension, Cuffed; 73110-050, size 5, Distal Extension, Uncuffed; 73110-060, size 6, Distal Extension, Uncuffed; 72110-070, size 7, Distal Extension, Uncuffed; 73110-080, size 8, Distal Extension, Uncuffed; 73120-050, size 5, Distal Extension, Cuffed; 73120-060, size 6, Distal Extension, Cuffed; 73120-070, size 7, Distal Extension, Cuffed; 73120-080, size 8, Distal Extension, Cuffed; 77100-050, size 5 XLT Disposal Inner Cannula; 77100-060, size 6 XLT Disposal Inner Cannula; 77100-070, size 7 XLT Disposal Inner Cannula; 77100-080, size 8 XLT Disposal Inner Cannula Manufactured by Mallinckrodt Medical, County Westmeath Cornamaddy, Athlone, Ireland; Customer Service: Mallinckrodt, Inc. St Louis, MO 63134
Product code: ---
Reason for recall: Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
FDA root cause: Other
Action: On 7/8/04, the firm initiated the recall. ***[After CDRH recommendations for class I recall situation, the firm issued PR via AP on 8/6/04.]*** .
Quantity in commerce: 71,021 units
Distribution: The tracheostomy tubes were distributed to 4,179 direct US and US Territory customers. The firm has also distributed products to Canada, the UK, Latin America and Japan. The firm's branches in those countries are handling the recall activities in those countries. The firm manufactured 95,923 units and distributed 71.021 throughout the US and US territories. 4,481 are on hold at the Nellcor distribution facility, and approximately 3000 units are currently in distribution.
Product codes and lots: All units of these models.

Product code ---

K003315Class IIShiley Tracheosoft Xlt Extended Length Tracheostomy Tube and Disposable Inner CannulaMallinckrodt, Inc. / cleared 2000-11-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)