Events

Recall of Device Recall TemnoChiba Soft Tissue Fine Aspiration Needle

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
    26426
  • Event Risk Class
    Class 2
  • Event Number
    Z-0942-03
  • Event Initiated Date
    2003-06-02
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27660
  • 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
    Instrument, Biopsy - Product Code KNW
  • Reason
    The product was shipped prior to being sterilized.
  • Action
    Recalled by telephone call and follow-up letter on 6/2/03. The accounts were informed that the biopsy needles were not sterile, and were requested to examine their inventory for the affected lot and return any found for credit and replacement.

Device

Device Recall TemnoChiba Soft Tissue Fine Aspiration Needle
  • Model / Serial
    Catalog number CHI1815, lot D03AB0594
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Florida, Georgia, Minnesota, Oklahoma, Ohio, Missouri and internationally to Malaysia.
  • Product Description
    Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, McGaw Park IL 60085
  • Source
    USFDA