Events

Recall of Device Recall Shiley FlexTra

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
    31273
  • Event Risk Class
    Class 2
  • Event Number
    Z-0721-05
  • Event Initiated Date
    2004-12-09
  • Event Date Posted
    2005-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37577
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal - Product Code JDH
  • Reason
    Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
  • Action
    On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the recall.

Device

Device Recall Shiley FlexTra
  • Model / Serial
    All codes are affected.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The firm has indicated that product was released for distribution to 7 consignees in US and to 17 foreign countries via international distribution centers. The firm has indicated that a very limited number of the product was distributed in the US to selected facilities that were participating in customer preference testing, after the device had received 510(k) clearance and all remaining stock was collected and returned to the company. Tyco Healthcare/Nellcor shipped Tyco Healthcare affiliate offices outside of the US. Foreign distribution include: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Holland, Italy, Norway, Poland, Singapore, Spain, Sweden, Switzerland and United Kingdom.
  • Product Description
    Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, || Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; || 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, || Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

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