Events

Recall of Device Recall Jostra Heater Cooler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MAQUET 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
    37023
  • Event Risk Class
    Class 2
  • Event Number
    Z-0350-2007
  • Event Initiated Date
    2006-11-10
  • Event Date Posted
    2007-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49779
  • 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
    The hcu 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. this may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.
  • Action
    Letters were mailed to customers on 11/10/2006 by Federal Express.

Device

Device Recall Jostra Heater Cooler
  • Model / Serial
    Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals in CA, NC, FL, WY, NY and WV.S
  • Product Description
    Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Manufacturer Address
    MAQUET Inc., 1140 US Highway 22, Bridgewater NJ 08807-2958
  • Source
    USFDA