Events

Recall of Device Recall Shiley TracheoSoft

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29653
  • Event Risk Class
    Class 1
  • Event Number
    Z-1312-04
  • Event Initiated Date
    2004-07-08
  • Event Date Posted
    2004-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34291
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code ---
  • 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.]*** .

Device

Device Recall Shiley TracheoSoft
  • Model / Serial
    All units of these models.
  • Product Classification
    Anesthesiology Devices
  • 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
    Nellcor Puritan Bennett

Manufacturer

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