Events

Recall of Device Recall CareFusion SmartSite Gravity Blood 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
    64204
  • Event Risk Class
    Class 2
  • Event Number
    Z-0832-2013
  • Event Initiated Date
    2012-12-20
  • Event Date Posted
    2013-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115553
  • 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 is recalling the smartsite¿ gravity blood set as a result of a potential for separation at the connection of the drip chamber and tubing . the separation may be observed at priming or observed during use. if a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
  • Action
    Carefusion sent an "URGENT: Medical Device Recall Notification" letter dated January 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to return all recalled product directly to the distributor from whom it was purchased immediately, complete and return the enclosed pre-addressed and postage paid mandatory Customer Recall Response Card and to contact your distributor directly, or call the Carefusion Support Center, if you have any questions. For questions Recall Related Questions contact CareFusion Support Center at 888-562-6018; 7am to 4pm (Pacific). For technical questions contact Technical Support at 888-812-3229, 7am to 5pm (Pacific).

Device

Device Recall CareFusion SmartSite Gravity Blood Set
  • Model / Serial
    Lot number 12055225
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
  • Product Description
    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products 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, 3750 Torrey View Ct, San Diego CA 92130-2622
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA