Events

Recall of Device Recall Temno

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
    56085
  • Event Risk Class
    Class 2
  • Event Number
    Z-2111-2010
  • Event Initiated Date
    2010-06-25
  • Event Date Posted
    2010-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92609
  • 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
    Guide, needle, surgical - Product Code GDF
  • Reason
    The introducer needle is only 10 cm in length instead of the required 15 cm.
  • Action
    Cardinal Health, on behalf of CareFusion, telephoned the customers on June 15, 2010 and sent a follow-up "URGENT: PRODUCT RECALL" letter on the same date via UPS next day air. The letter describes product, problem, and action taken by customers. The customers were instructed to immediately stop using affected product, return the enclosed acknowledgment form via fax to 847-686-9101 (note: Cardinal Health is required to confirm receipt of this notification from the customers), notify any customers to whom they may have distributed product to, contact CareFusion Customer Service at 800-653-6827 to arrange for credit and return of the affected product, and send the affected product to CareFusion, 1240 Waukegan Rd, Waukegan, IL 60085, Attn: Scott Fitzer, after obtaining an RMA/RGA number from CareFusion. If you have any questions, please contact 800-292-9332.

Device

Device Recall Temno
  • Model / Serial
    Catalog number CCH2220, Lot D09121745
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.
  • Product Description
    Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Made in Dominican Republic; REF CCH2220 || For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Manufacturer Address
    Carefusion 2200 Inc, 1500 S Waukegan Rd, Mpwm Bldg., Waukegan IL 60085-6728
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA