Events

Recall of Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southmedic, Inc..

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
    78568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1288-2018
  • Event Initiated Date
    2017-10-17
  • Event Date Posted
    2018-01-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159778
  • 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
    Potential for loose or missing co2 diffusers which could result in a non-functioning mask.
  • Action
    Customers were notified via letter on October 17, 2017. Instructions included checking inventory for affected devices and quarantining any found, complete and return the Voluntary Recall Notification Confirmation Form, and arrange for the return of any affected products. On February 14, 2018, the recall was expanded and customers were notified. Instructions were the same as the original notification, but updated the Part/Lot information. For further questions, please call 1 (800) 463-7146

Device

Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.
  • Model / Serial
    Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668);  OK-2125-8 (W37602, W37898, W39852, W40051, W40863);  OK-2125-8SLM (W36957, W39164, W39695, W41454);  OM-2125-14 (W36512, W38338);  OM-2125-14SLM (W35876, W39251, W40873);  OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668);  OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546);  OM-2325-8(W38340);  OP-2125-14 (W37273, W39697);  OP-2125-8 (W37031, W38005, W38190, W39027, W39851);  OP-2125-8SLM (W37901, W38692, W39253, W41447)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of California, and Internationally to Canada and Sweden
  • Product Description
    Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. || Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
  • Manufacturer
    Southmedic, Inc.

Manufacturer

Southmedic, Inc.
  • Manufacturer Address
    Southmedic, Inc., 50 Alliance Blvd, Barrie Canada
  • Manufacturer Parent Company (2017)
    Southmedic, Inc.
  • Source
    USFDA