Nellcor Puritan Bennett: 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

Recall number

Z-1312-04

Recalling firm

Nellcor Puritan Bennett

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

Status

Terminated

Initiated

2004-07-08

Posted

2004-08-07

Terminated

2005-11-29

Reason

Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.

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

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.

Lot, serial or model codes

All units of these models.

510(k) numbers

["K003315"]

PMA numbers

not on file

Product code

---

Firm FEI

2936999

Firm city

Pleasanton

Firm state

CA

Firm country

not on file

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

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