Events

Recall of KOOL-KIT NEONATE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CINCINNATI SUB-ZERO PRODUCTS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75528
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    Model Catalog: 950 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    KOOL-KIT NEONATE
  • Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS

Manufacturer

CINCINNATI SUB-ZERO PRODUCTS
  • Manufacturer Address
    CINCINNATI
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    HC