Events

Recall of Device Recall ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery

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
    60658
  • Event Risk Class
    Class 2
  • Event Number
    Z-0605-2012
  • Event Initiated Date
    2011-12-07
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106145
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Reason
    Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707f (with female luer lock connectors).
  • Action
    The firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690.

Device

Device Recall ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery
  • Model / Serial
    Lot 090610
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- TX and VA.
  • Product Description
    ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. || Salter Labs Nasal Cannula (Adult), Salter Style || with modified nasal prongs. || w/7' O2 line and 7' CO2 line with male luer lock connector. || Salter Labs || 100 W. Sycamore Road, || Arvin, CA 93203
  • Manufacturer
    SALTER LABS

Manufacturer

SALTER LABS
  • Manufacturer Address
    SALTER LABS, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA