Events

Recall of Device Recall WarmAir 135

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cincinnati Sub-Zero Products Inc.

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
    51228
  • Event Risk Class
    Class 2
  • Event Number
    Z-0035-2010
  • Event Initiated Date
    2009-02-16
  • Event Date Posted
    2009-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79327
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Thermal regulating system - Product Code DWJ
  • Reason
    The blower on the warmair 135 warming unit may overheat. resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
  • Action
    The firm sent an "URGENT Medical Device Recall' notice via First Class Mail on 2/16/2009 (Note: the letter is dated 2/13/2009). The notice informs the customers of the potential for the device to overheat and of the 'small number of customer complaints received by CSZ concerning this issue. In addition, the notice asks that the customers inspect their units for signs of discoloration indicative of a faulty connector. In the notice, the customers were instructed to return the product to CSZ for repair by contacting their Customer Service division and obtaining a Return Authorization number and specific instructions concerning packaging and returning of the unit(s) for repair. The customer is also instructed to complete the attached Recall Response Form which accompanies the recall notification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution for customer use.

Device

Device Recall WarmAir 135
  • Model / Serial
    Serial Numbers 994-1350001 to 083-1355822..
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT, VA, CO, MO, IA, AZ, AR, IN, NE, KS, WI, ME, MS, and Puerto Rico.
  • Product Description
    WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming || patients before, during and after surgery, and other specialty procedures.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Manufacturer Address
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    USFDA