Events

Recall of Device Recall CareFusion, SnowdenPencer, DiamondFlex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 2200 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
    74465
  • Event Risk Class
    Class 1
  • Event Number
    Z-2212-2016
  • Event Initiated Date
    2016-07-01
  • Event Date Posted
    2016-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147639
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Reason
    Bd, formerly carefusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. if this failure were to occur while in use in a procedure it has the potential to damages tissue or organs.
  • Action
    BD, sent an "URGENT: Medical Device/ Safety Alert/Recall Notification" letter dated 6/30/2016 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the affected units, along with the enclosed CUSTOMER RESPONSE FORM to: BD formerly CareFusion, 75 North Fairway Drive, Vernon Hills, Illinois, 60061 Attn: Customer Advocacy; to expedite the correction process and acknowledge receipt of the notification. The firm will issue a credit upon receipt of the returned affected product. For questions and support 1-800-323-9088 Prompt 3 or email: GMB-US-Complaint-Intake@carefusion.com.

Device

Device Recall CareFusion, SnowdenPencer, DiamondFlex
  • Model / Serial
    Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
  • Product Description
    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. || Designed to retract or elevate organs and tissue to provide better visualization access.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Manufacturer Address
    Carefusion 2200 Inc, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA