Events

Recall of Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vyaire Medical.

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
    77845
  • Event Risk Class
    Class 2
  • Event Number
    Z-3080-2017
  • Event Initiated Date
    2017-07-18
  • Event Date Posted
    2017-08-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158028
  • 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
    Arterial blood sampling kit - Product Code CBT
  • Reason
    Lot #0001047501 of the 9025rhtr abg sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 gage, 1" needle), larger syringe (3ml), and larger amount of heparin (113iu), than what is intended for the kit.
  • Action
    The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated 07/18/2017 to its consignees. The letter described the product, problem and actions to be taken. Thee consignees were directed to inspect their current inventory and remove the recalled lot. Distributors and direct consignees were instructed to complete the Customer Response Form and return to GMB-GLB-ALFieldActions and destroy the product. If you wish to obtain credit/replacement contact Vyaire Customer Support at (800) 323.9008 (option #1) Monday-Friday 8:00am CST - 5:oopm CST. Distributors were instructed to notify their customers and have them respond directly to the distributor. For any additional questions and support concerning this voluntary Recall, please contact Clinical Risk Coordinator, at (224)706-6830 or Lindy.Schenning@Vyaire.com.

Device

Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit
  • Model / Serial
    Lot Number 0001047501
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
  • Product Description
    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION || Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical
  • Manufacturer Address
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Manufacturer Parent Company (2017)
    Vyaire Holding Company
  • Source
    USFDA