Events

Rappel de KOOL-KIT NEONATE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CINCINNATI SUB-ZERO PRODUCTS.

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
    75528
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-10-31
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Cincinnati sub-zero products inc. (csz) has initiated a correction on this medical device due to the omission of the probe ifu from the kool-kit neonate. the kool-kit neonate has been designed such that 1 of the individually packaged cat #491b probes is required for each tray. since the probes are received from their manufacturer in cartons containing 20 probes and 1 ifu 1 carton of probes will make 20 kool-kit neonate trays. the probe ifu has not been used during assembly of the kool-kit neonate trays since the product was first released for sale on 3/27/2009. however since the probe pouches are labeled with a 3 year shelf life this correction only applies to kool-kit neonates manufactured within the last 3 years. the probe ifu includes additional information that is not included within the labeling provided to the customer by csz.

Device

KOOL-KIT NEONATE
  • Modèle / numéro de série
    Model Catalog: 950 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    KOOL-KIT NEONATE
  • Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS

Manufacturer

CINCINNATI SUB-ZERO PRODUCTS
  • Adresse du fabricant
    CINCINNATI
  • Société-mère du fabricant (2017)
    Gentherm, Inc.
  • Source
    HC