Events

Recall of Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector

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
    62272
  • Event Risk Class
    Class 2
  • Event Number
    Z-1898-2012
  • Event Initiated Date
    2012-05-30
  • Event Date Posted
    2012-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110043
  • 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
    A complaint was received, and later verified, that product labeled as so-1296 with male luer lock connector actually contained product with a female luer lock connector.
  • Action
    The firm, Salter Labs, called their customers to discuss the recall and followed up with a "PRODUCT RECALL" letter dated May 29, 2012. The letter was distributed to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any of the lots in their possession to Salter Labs; contact Salter Labs Customer Service at 1-800-235-4203 to arrange for return of the product, and complete and return the attached form/record 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

Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector
  • Model / Serial
    Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
  • Product Description
    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. || 7 ft, oxygen tube, 7 ft. CO2 tube || RX only.For Single Patient Use only. || Distributed by Tri-Anium || Assembled in Mexico. || Usage: Delivery of Anesthesia.
  • Manufacturer
    SALTER LABS

Manufacturer

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