Events

Rappel de Device Recall Infant AirLife

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 Vyaire Medical.

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
    78636
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0343-2018
  • Date de mise en oeuvre de l'événement
    2014-11-29
  • 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=160040
  • 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
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Cause
    Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. the may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
  • Action
    The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated November 29th, 2017 to its customers. The recall letter described the product, problem and actions to be taken. The customers were instructed to do the following: "ALL CUSTOMERS: ~ Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove affected lots of the AirLife Humidification Chamber(s) and Heated Breathing Circuit Kit(s) due to the identified potential patient safety risk. ~ Destroy all affected product(s) in-stock in accordance with your facility's destruction protocol. ~ If you are a healthcare facility or distributor that has further distributed affected product you must further notify your customers of this URGENT RECALL NOTIFICATION. CUSTOMERS THAT HAVE PURCHASED DIRECT FROM VYAIRE: ~ Complete the Customer Response Form (Appendix 2) and return to GMB-GLBALFieldActions@CareFusion.com ~ If you wish to receive credit of your in-stock product affected by this recall or to place an order for the replacement Model/Part Numbers (as referenced per #6. Per the FAQ's) please contact Vyaire Medical's Customer Service Department at 800.323.9088 (Option #1, followed by Option #1) Monday-Friday 8:00 am CST - 5:00 pm CST. *Please have your original PO number available when calling to expedite the credit process. CUSTOMERS THAT HAVE PURCHASED THROUGH A DISTRIBUTOR: ~ Please work with your distributor to receive credit of your in-stock product affected by this recall. For any additional questions and support concerning this voluntary recall, please contact Clinical Risk Coordinator, at 827-757-0109 or lindy.schenning@vyaire.com.

Device

Device Recall Infant AirLife
  • Modèle / numéro de série
    CM17H12 CM17H16 CM17H17 CM17H19 CM17H20 CM17J27 CM17J28 CM17J29 CM17J30 CM17K09 CM17K20 CM17K21 CM17K22 CM17K23
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. || The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical
  • Adresse du fabricant
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Société-mère du fabricant (2017)
    Vyaire Holding Company
  • Source
    USFDA