Events

Recall of Device Recall enFlow Disposable IV Fluid/Blood Warmer Cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs 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
    56561
  • Event Risk Class
    Class 2
  • Event Number
    Z-2380-2010
  • Event Initiated Date
    2010-07-15
  • Event Date Posted
    2010-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93970
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • Reason
    The enflow disposable iv fluid/blood warmer cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.
  • Action
    GE Healthcare issued an "Urgent Medical Device Correction" letter, dated July 15, 2010, to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and quarantine the affected devices, and contact Vital Signs Inc. Customer Service to arrange for return and replacement of the affected devices. Consignees were instructed to complete and return the Confirmation Form. Consignees can contact Vital Signs Inc. Customer Service at 1-973-956-5300 .

Device

Device Recall enFlow Disposable IV Fluid/Blood Warmer Cartridge
  • Model / Serial
    Model numbers: 9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210, 91000153, 91000154, 91000156. Master lot numbers on shipping cartons: oo1K through 365K, 001P through 365P, 001S through 365S.  Shelf carton and unit level lot numbers" 0901xxxx through 1001xxxx
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.
  • Product Description
    Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.
  • Manufacturer
    Vital Signs Inc

Manufacturer

Vital Signs Inc
  • Manufacturer Address
    Vital Signs Inc, 20 Campus Rd, Totowa NJ 07512
  • Manufacturer Parent Company (2017)
    Vyaire Holding Company
  • Source
    USFDA