Events

Recall of Salter Laboratories Adult Nasal Cannula

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
    58564
  • Event Risk Class
    Class 2
  • Event Number
    Z-2242-2011
  • Event Initiated Date
    2011-04-19
  • Event Date Posted
    2011-05-23
  • 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=99597
  • 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
    One complaint received of product in box different from what was on label.
  • Action
    Salter Laboratories sent a URGENT PRODUCT RECALL NOTIFICATION letter dated April 19, 2011, certified mail to all of the affected consignees, along with a RECALL EFFECTIVENESS CHECK FORM to acknowledge receipt of this communication. It was reported that a package labeled 1600-14, Adult Nasal Cannula actually contained a 25-foot length of tubing and has determined that additional product may have been incorrectly labeled in this manner. No illness or injury would result from this product mix-ups. Should you have any questions, please contact Salter Laboratories at 1-800-235-4203.

Device

Salter Laboratories Adult Nasal Cannula
  • Model / Serial
    Product code 1600-14-50, Lot number 032210
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of South America.
  • Product Description
    Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. || Single Patient use. Do not sterilize. || 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