Events

Rappel de Thayer MiniSpacer Dual Spray MDI Adapter

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 Thayer Medical Corporation.

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
    75338
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1146-2017
  • Date de publication de l'événement
    2017-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150065
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • Cause
    The insert and case label description of the device incorrectly reads counter incrementing actuator with 22mm o.D./i.D. connections.
  • Action
    Thayer Medical sent an Urgent Medical Device Recall letter dated September 30, 2016, to all affected customers. The letter informed customers that Thayer Medical has identified a labeling error on REF 1543A, Thayer MiniSpacer Dual Spray MDI Adapter with Counter Incrementing Actuator and 15mm O.D./I.D. Connections. Customers were informed to complete and return the attached Customer Reply Form by email to info@thayermedical.com or fax to 1-520-790-5854. For questions regarding this recall call 520-790-5393, ext 2210.

Device

Thayer MiniSpacer Dual Spray MDI Adapter
  • Modèle / numéro de série
    160214, 160301, 160901
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. || The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream
  • Manufacturer
    Thayer Medical Corporation

Manufacturer

Thayer Medical Corporation
  • Adresse du fabricant
    Thayer Medical Corporation, 4575 S Palo Verde Rd Ste 337, Tucson AZ 85714-1961
  • Société-mère du fabricant (2017)
    Thayer Medical Corporation
  • Source
    USFDA