Events

Recall of Device Recall BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arizant 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
    54487
  • Event Risk Class
    Class 2
  • Event Number
    Z-0895-2010
  • Event Initiated Date
    2009-12-17
  • Event Date Posted
    2010-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88575
  • 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
    system, thermal regulating - Product Code DWJ
  • Reason
    Arizant healthcare inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (arizant part number 502221 model 90024) attached to its temperature management units and pressure infusion power pack (bair paws¿ temperature management units: models 850 and 875 bair hugger¿ temperature management units: models 500/or, 505 (human & vet.), 750 (human & vet) and 775 ranger¿ blood/flui.
  • Action
    An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.

Device

Device Recall BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
  • Model / Serial
    Part number 502221 Model 90024
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.
  • Product Description
    Electri-Cord Manufacturing Corporation(312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Pressure Infusion Power Pack; Model 90033. || To provide power to pressure infusers.
  • Manufacturer
    Arizant Inc

Manufacturer

Arizant Inc
  • Manufacturer Address
    Arizant Inc, 10393 W 70th St, Eden Prairie MN 55344
  • Source
    USFDA