Events

Recall of Device Recall Oridion

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oridion Medical 1987 Ltd..

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
    61329
  • Event Risk Class
    Class 2
  • Event Number
    Z-1334-2012
  • Event Initiated Date
    2012-02-16
  • Event Date Posted
    2012-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107811
  • 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
    Co2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
  • Action
    Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.

Device

Device Recall Oridion
  • Model / Serial
    All lots
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Oridion CO2 sampling lines and water traps under the label: || Omnistream CO2 Sampling Lines: || OmniLine O2 Adult Part No.007609; || OmniLine O2 Pediatric Part No 007610; || Smart OmniLine Plus O2 Adult Part No.010177; || Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; || Smart OmniLine O2 Pediatric Part No. 007606; || ;Smart OmniBloc O2 Part No. 010946 || Smart OmniLine Plus part No. 010172 || Smart OmniLine Plus (package of 100 units) Part No 010212; || Smart OmniLine Guardian O2 Part No. 012531; || Smart OmniLine Guardian O2 Long Part No. 012532 || OmniVentLine Set Part No. 012495
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

Oridion Medical 1987 Ltd.
  • Manufacturer Address
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA