Device Recall Shiley TracheoSoft

  • Model / Serial
    All units of these models.
  • Product Classification
  • 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 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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Nellcor Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
  • Source
    USFDA