Events

Recall of HuFriedy

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hu-Friedy Mfg Co, 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
    25958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0802-03
  • Event Initiated Date
    2003-04-10
  • Event Date Posted
    2003-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26774
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code GAB--
  • Reason
    The suture needles were mislabeled with the wrong size.
  • Action
    Hu-Friedy sent recall letters dated 4/10/03 to their accounts on the same date, informing them that the incorrect size needle was packaged as SN4 suture needles, and requesting them to quarantine all warehouse stocks of SN4 suture needles for return to Hu-Friedy for replacement and to notify their sub-accounts.

Device

HuFriedy
  • Model / Serial
    Partcode SN4, all units distributed between 1/3/01 and 3/10/03.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Michigan, Massachusetts, California, Pennsylvania, Texas, Washington, New York, Wisconsin, Iowa, Indiana, Tennessee, New Jersey, Louisiana, South Carolina, Florida, and internationally to Canada, Australia and New Zealand.
  • Product Description
    Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618
  • Manufacturer
    Hu-Friedy Mfg Co, Inc.

Manufacturer

Hu-Friedy Mfg Co, Inc.
  • Manufacturer Address
    Hu-Friedy Mfg Co, Inc., 3232 N Rockwell, Chicago IL 60618-5935
  • Source
    USFDA