Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Southmedic, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78568
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1288-2018
  • Date de mise en oeuvre de l'événement
    2017-10-17
  • Date de publication de l'événement
    2018-01-25
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159778
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Cause
    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.
  • Modèle / numéro de série
    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)
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the state of California, and Internationally to Canada and Sweden
  • Description du dispositif
    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.
  • Adresse du fabricant
    Southmedic, Inc., 50 Alliance Blvd, Barrie Canada
  • Société-mère du fabricant (2017)
    Southmedic, Inc.
  • Source
    USFDA