BEUDAMED
    FDA Recall 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

    Recall: Z-1312-04 · Initiated July 8, 2004

    Recall

    Recall Number
    Z-1312-04
    Event Number
    29653
    Firm
    Nellcor Puritan Bennett
    FEI Number
    2936999
    Product Code
    ---
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 8, 2004
    Posted
    August 7, 2004
    Terminated
    November 29, 2005
    Address
    4280 Hacienda Dr, Pleasanton, CA, 94588-2719

    Description

    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

    Reason

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

    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.]*** .

    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.

    Quantity

    71,021 units