Events

Rappel de Device Recall ECOLAB MICROTEK Rolled Probe Cover

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 ECOLAB 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
    80160
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2333-2018
  • Date de mise en oeuvre de l'événement
    2017-11-22
  • Statut de l'événement
    Completed
  • 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=164717
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Cause
    The incorrect ifu was shipped with the product.
  • Action
    The recalling firm issued letters dated November 21, 2017, informing the customer the incorrect IFU was shipped with the product and a correct version of the IFU is being provided with the letter. The consignee was requested to notify downstream customers to the user level and that a copy of the letter could be forwarded to enhance communication. A Recall Response Form was enclosed for completion to be returned via FAX or email as soon as possible. The letter also informs the consignee that the recalling firm will send additional replacement IFU's if they have product in inventory. For further questions, please call (651) 250-4385.

Device

Device Recall ECOLAB MICROTEK Rolled Probe Cover
  • Modèle / numéro de série
    Lot numbers D152291, D160961, D161161, D161311, D161371, and D161721.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
  • Description du dispositif
    ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. || To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
  • Manufacturer
    ECOLAB INC

Manufacturer

ECOLAB INC
  • Adresse du fabricant
    ECOLAB INC, 1 Ecolab Pl, Saint Paul MN 55102-2739
  • Société-mère du fabricant (2017)
    Ecolab Inc
  • Source
    USFDA