Events

Recall of Device Recall Salter Labs EtCO2 Sample line

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
    66720
  • Event Risk Class
    Class 2
  • Event Number
    Z-0360-2014
  • Event Initiated Date
    2013-11-01
  • Event Date Posted
    2013-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123119
  • 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
    It has been determined that three lots of model number 4515-15-25 co2 sample line 15' tube, male luer lock connectors may contain a 30' tube instead of the 15' length.
  • Action
    Salter Labs called the five customers that received product from the three lots, then follow-up immediately by sending a recall notification letter directly to each customer. Each letter will identify all shipments of subject product that they received. All customers letters were sent certified mail, return receipt requested.

Device

Device Recall Salter Labs EtCO2 Sample line
  • Model / Serial
    Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.
  • Product Description
    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. || Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, || Arvin, CA 93203. || CO2 sample line.
  • Manufacturer
    SALTER LABS

Manufacturer

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