Events

Recall of WARMAIR HYPERTHERMIA UNIT

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
    148313
  • Event Risk Class
    III
  • Event Initiated Date
    2011-08-17
  • 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
    In 2009 fda cited cincinnati sub-zero products inc. (csz) for not obtaining proper clearance for the warmair model 135 device fda did not accept csz's rationale for not requiring 510(k) clearance on the device. as a corrective action csz submitted an application for clearance. in october 2010 csz received 510(k) clearance of the warmair 135 device. during the review process however csz made changes to the warmair 135 manual. prior to receiving 510(k) clearance the device was also certified to iec 60601-1-2 which required additional changes to the manual (which were included with the 510(k) submission).

Device

WARMAIR HYPERTHERMIA UNIT
  • Model / Serial
    Model Catalog: 135 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    WARMAIR MODEL 135
  • Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS

Manufacturer

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