Events

Recall of Device Recall Arizant Bair Hugger Temperature Management Blanket

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
    31379
  • Event Risk Class
    Class 2
  • Event Number
    Z-0855-05
  • Event Initiated Date
    2005-03-11
  • Event Date Posted
    2005-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37753
  • 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
    Air channel seals on a limited number of bair hugger model 555 pediatric underbody blankets could separate when inflated with air from bair hugger warming unit. this separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.
  • Action
    Recall notification was mailed to customers beginning 03/11/05. Customers were informed of the issue and asked to check their inventory for the affected lots. Affected lots found are to be quarantined and customers are to contact Arizant for instruction on returning affected product and receiving replacement product. Distributors are instructed to examine their inventory for affected lots, discontinue distribution and quarantine the lots. Distributors are asked to contact Arizant for returning affected product. If affected product was distributed, Distributors are to contact Arizant with names, addresses and telephone numbers of their accounts so Arizant can immediately inform those accounts of the recall.

Device

Device Recall Arizant Bair Hugger Temperature Management Blanket
  • Model / Serial
    lot numbers ranging from 9631 up to and including 9657
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide
  • Product Description
    Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been previously opened or is damaged. Arizant Healthcare Inc., 10393 West 70th Street, Eden Prairie, MN 55344 USA.
  • Manufacturer
    Arizant Inc

Manufacturer

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