Events

Recall of Device Recall Warm Air Model !35

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    30414
  • Event Risk Class
    Class 2
  • Event Number
    Z-0374-05
  • Event Initiated Date
    2004-11-05
  • Event Date Posted
    2004-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35826
  • Notes / Alerts
    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 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 data.
  • Extra notes in the data
    unknown device name - Product Code BTE
  • Reason
    Burning smell, burned microprocessor board. the firm is modifying the connectors and wiring gauge configuration of the device.
  • Action
    The firm notified consignees by certified letter on November 5, 2004.

Device

Device Recall Warm Air Model !35
  • Model / Serial
    All serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Distribution
    The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.
  • Product Description
    Warm Air Model 135 Warming Units.
  • Manufacturer
    Cincinnati Sub-Zero Products

Manufacturer

Cincinnati Sub-Zero Products
  • Manufacturer Address
    Cincinnati Sub-Zero Products, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Source
    USFDA