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Terminated

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

FDA Recall Z-1312-04 · Posted 2004-08-07

Recalling FirmNellcor Puritan Bennett
Recall StatusTerminated
Date Initiated2004-07-08
Date Terminated2005-11-29
Product Quantity71,021 units

Reason for Recall

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

Firm 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.]*** .

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003315SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAMallinckrodt, Inc. · 2000-11-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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