Events

Recall of Device Recall Huber TrapA Safety Huber Needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Multi-Med, 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
    56548
  • Event Risk Class
    Class 1
  • Event Number
    Z-2554-2010
  • Event Initiated Date
    2010-08-30
  • Event Date Posted
    2010-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94022
  • 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
    Hypodermic Single Lumen Needle - Product Code FMI
  • Reason
    Huber needles may core and result in port leakage or emboli being flushed our of the port.
  • Action
    Multi-Med issued an Urgent: Medical Device Recall notification on 8/30/10 via fax and followed by hard copy letter. Users were advised of the problem and asked to immediately examine their inventory and quarantine the affected product. They were to also notify their customers of the recall. The firm stated in the letter that they would contact customers to determine the number of product that they had and the amount they expected from the field. The firm will coordinate a plan for the return of the affected product. Questions should be directed to Sue Starkey at 603-357-8733.

Device

Device Recall Huber TrapA Safety Huber Needle
  • Model / Serial
    Lot Codes: 5H028M 5I051M 6K050M 7G033M 7G047M 7H023M
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Mexico.
  • Product Description
    Marquette Medical Huber Trap-A Safety Huber Needle || 19ga x .75" Winged Administration Set w/Y Site || Model # MW193Y || Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.
  • Manufacturer
    Multi-Med, Inc.

Manufacturer

Multi-Med, Inc.
  • Manufacturer Address
    Multi-Med, Inc., 26 Victoria Court, Keene NH 03431
  • Manufacturer Parent Company (2017)
    Multi-Med, Inc.
  • Source
    USFDA