Events

Recall of Device Recall Arizant Healthcare Ranger Blood/Fluid Warming Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arizant Healthcare, 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
    38409
  • Event Risk Class
    Class 2
  • Event Number
    Z-1183-2007
  • Event Initiated Date
    2007-06-26
  • Event Date Posted
    2007-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53633
  • 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
    Blood/Fluid Warming Set - Product Code FPA
  • Reason
    Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
  • Action
    All consignees will be contacted by Urgent Medical Device Recall letter on 6/26/07.

Device

Device Recall Arizant Healthcare Ranger Blood/Fluid Warming Set
  • Model / Serial
    Lots B4798 through B4803 and Lot E5111
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of United Kingdom, France, Switzerland, Germany, India, Canada, Australia, Netherlands, Italy, Sweeden, South Korea, and Greece.
  • Product Description
    Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit.
  • Manufacturer
    Arizant Healthcare, Inc

Manufacturer

Arizant Healthcare, Inc
  • Manufacturer Address
    Arizant Healthcare, Inc, 10393 W 70th St, Eden Prairie MN 55344-3446
  • Manufacturer Parent Company (2017)
    Arizant Healthcare Inc
  • Source
    USFDA