Events

Recall of Nasal Cannula (Adult) Salter Style

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Salter Laboratories, Division of Regulatory Affairs.

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
    58563
  • Event Risk Class
    Class 2
  • Event Number
    Z-2237-2011
  • Event Initiated Date
    2011-04-19
  • Event Date Posted
    2011-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99596
  • 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
    Complaint received that the product in the box was different from labeled product.
  • Action
    The firm, Salter Labs, sent an "URGENT PRODUCT RECALL" subtitled Adult Divided Cannula Product Code 4707 Lot 012411, letter dated April 19, 2011 via certified mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory; return any of the lot in their possession to Salter; contact Salter Customer Service at 1-800-235-4203 to arrange for the return of the product, and complete and return the Customer Reply Form via fax to 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Device

Nasal Cannula (Adult) Salter Style
  • Model / Serial
    Product Code: 4707-7-7-25, Lot code 012411
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula. || Single Patient Use. Do not Sterilize || Salter Labs, 100 W. Sycamore Road, Arvin, CA 93293 || Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.
  • Manufacturer
    Salter Laboratories, Division of Regulatory Affairs

Manufacturer

Salter Laboratories, Division of Regulatory Affairs
  • Manufacturer Address
    Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA