Events

Recall of Device Recall Hemotherm

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

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
    78173
  • Event Risk Class
    Class 2
  • Event Number
    Z-0629-2018
  • Event Initiated Date
    2017-11-27
  • Event Date Posted
    2018-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158835
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • Reason
    Due to fda's safety communication relating to nontuberculous mycobacteria (ntm) infections related to heater/cooler devices, an updated instructions for use includes a more robust cleaning & disinfection procedure.
  • Action
    Between November 27, 2017 - December 8, 2017, Cincinnati Sub-Zero Products LLC, distributed Urgent Medical Device Correction notices to their customers via Email and USPS. This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures. The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm. Customers are encouraged to do the following: 1) Discard your current Hemotherm Operation & Technical Manual and/or Operation Manual. 2) Replace your current Hemotherm Operation & Technical Manual and/or Operation Manual with the enclosed updated Manual(s). For your convenience, all updates have been highlighted in the manuals. " For Hemotherm 400CE users, utilize the P/N 56418-R Operation & Technical Manual and P/N 56075-G Operation Manuals. " For Hemotherm 400MR users, utilize the P/N 56234-S Operation Manual. All customers are encouraged to complete and return the enclosed response form by fax or email to FA2016-009@genthermcsz.com; Fax: 513-772-9119. Customers with questions or concerns, please contact the Field Action Coordinator: Kathy DeSmidt, E-mail: FA2016-009@genthermcsz.com, Phone: 513-772-8810 or 800-989-7373.

Device

Device Recall Hemotherm
  • Model / Serial
    none
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR || Product Usage: || A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
  • Manufacturer
    Cincinnati Sub-Zero Products LLC

Manufacturer

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