Events

Recall of Intravascular Administration Set and Extension Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 303, 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
    58576
  • Event Risk Class
    Class 2
  • Event Number
    Z-2707-2011
  • Event Initiated Date
    2011-04-20
  • Event Date Posted
    2011-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99619
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Carefusion has initiated a product recall for the maxplus bifuse extension set (minibore) needleless connectors model mp9232-c as a result of a potential for occlusion. the product may be occluded at the bifused component.
  • Action
    CareFusion initiated on May 3, 2011, two distinctive "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via mail delivery, to all affected customers and distributors. The notices identified the product, the problem, and the actions to be taken. Customers were instructed to 1.) Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card to CareFusion. Note on the card your distributor, the MaxPlus bifuse extension set lot numbers and quantities that will be returned. 2.) All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods number through their distributor or CareFusion. 3.) Also, enclosed is a Frequently Asked Question (FAQ) Letter to address any questions or concerns related to the use of the MaxPlus" bifuse extension sets. The second notification was specifically addressed to distributors. The distributors were provided specific instructions for product returned. For customers who may have questions, please contact your distributor directly, or call the CareFusion Support Center at 1-800- 562-6018. The Support Center will be in operation from 7 a.m. - 4 p.m. PST. For distributors who may have any questions or require additional materials, please contact the CareFusion Support Center at 1800- 562-6018. Additionally, instructions were given to report adverse reactions experienced via the FDA's Med Watch Program.

Device

Intravascular Administration Set and Extension Set
  • Model / Serial
    Lot Numbers: 10128001, 11018001, 11018002, 11018003, 11018007, 11018012, 11018013.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- USA including states of: CA, IA, IN, and TX
  • Product Description
    MaxPlus bifuse extension set (minibore) needleless connectors, || Model Number: MP9232-C || Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
  • Manufacturer
    Carefusion 303, Inc.

Manufacturer

Carefusion 303, Inc.
  • Manufacturer Address
    Carefusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA