Events

Recall of Device Recall 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 Cardinal Health.

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
    74706
  • Event Risk Class
    Class 2
  • Event Number
    Z-2713-2016
  • Event Initiated Date
    2016-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148260
  • 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
    Arterial blood gas (abg) kit- missing safety component. the abg kit(s) have been identified as missing the locking clasp component. carefusion/bd has identified a potential customer/user safety risk associated with the missing locking clasp component.
  • Action
    CareFusion/BD sent out a FIELD SAFETY NOTICE of the field correction in writing on June 27, 2016. The letter described the nature of the recall and provided actions to be performed. Carefusion/BD directed customers to take the following actions: Step #1: Inspect current inventory on-hand to identify the presence of the affected Arterial Blood Gas Sampling Kit(s). Step #2: Complete the Customer Response Form by checking all appropriate boxes and providing all accurate information as required. Step #3: Destroy all affected product(s) in-stock in accordance with their facility's destruction protocol. Step #4: Return the Customer Response Form to GMB-GLB-ALFieldActions@CareFusion.com Step #5: If the customers want to obtain credit and/or replacement of destroyed product(s) they are asked to call their CareFusion/BD Customer Support Department at 800.323.9088 (Option #1 ). For any additional questions and support concerning the voluntary Field Safety Corrective Action, customers are asked to call (847)362.9303.

Device

Device Recall Arterial Blood Gas (ABG) Sampling Kit
  • Model / Serial
    Three (3) total lots (lot #884993, lot #903136 & lot #903137).
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada.
  • Product Description
    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1300 Waukegan Rd, Waukegan IL 60085-6724
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA