Events

Recall of Device Recall Cardiopulmonary bypass temperature controllers

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
    58971
  • Event Risk Class
    Class 2
  • Event Number
    Z-2721-2011
  • Event Initiated Date
    2011-05-02
  • Event Date Posted
    2011-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100747
  • 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
    Cardiovascular Thermal Regulating System - Product Code DWJ
  • Reason
    The probe jack contacts (terminals) on certain of the firm's ecmo heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. if this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
  • Action
    Cincinnati Sub-Zero Products Inc issued an "Urgeant Medical Device Field Action" letter on May 2, 2011 to all affected customers. The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form. For additional contact the firm at 1-800-989-7373 or (513) 772-8810.

Device

Device Recall Cardiopulmonary bypass temperature controllers
  • Model / Serial
    Model: 333W Part Number: 86135 (115V), 86136 (230V) and 86138 (240V) Serial Number: 942-E2979 through 031-E5150
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, and WI.
  • Product Description
    ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. || This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.
  • 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
  • Manufacturer Parent Company (2017)
    Gentherm, Inc.
  • Source
    USFDA