Events

Recall of Device Recall Tpiece Nebulizer with inline connectors

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

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
    73130
  • Event Risk Class
    Class 2
  • Event Number
    Z-0796-2016
  • Event Initiated Date
    2016-01-05
  • Event Date Posted
    2016-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143122
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • Reason
    Reports that the t-piece does not fit on the nebulizer.
  • Action
    A customer letter dated 1/13/16 was sent to all customers who purchased the T-piece Nebulizer with in-line connectors because of reports that the T-piece does not fit on the nebulizer. The letter informs the customers that there has been no reports of interruption or delay in therapy. Customers are instructed to contact Salter Labs Customer Service at 1-800-421-0024 to arrange for the return of the product and replacement inventory. Customers are instructed to acknowledge receipt of the communication by completing the attached reply form and faxing it to the number indicated on the attached form. Customers are instructed to contact Salter Labs Customer Support at 800-421-0024 or your local Salter Labs representative to document any issues that you have encountered or to request replacement inventory.

Device

Device Recall Tpiece Nebulizer with inline connectors
  • Model / Serial
    Lot No. 083115, 090715, and 122815
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
  • Product Description
    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
  • Manufacturer
    Salter Labs

Manufacturer

Salter Labs