Events

Recall of Device Recall 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
    55824
  • Event Risk Class
    Class 1
  • Event Number
    Z-1888-2010
  • Event Initiated Date
    2010-05-26
  • Event Date Posted
    2010-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91966
  • 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
    needle, hypodermic, single - Product Code FMI
  • Reason
    Fda sample determined the needles to be coring.
  • Action
    The firm, Multi Med, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 26, 2010 to their sole consignee Navilyst Medical, Inc., via email and overnight courier with signature notification. The letter describes the product, problem and action to be taken by customer. The customers was instructed to immediately examine their inventory and quarantine product subject to recall, if the product was distributed to others customers, identify and notify them at once and include recall notification letter,. Recall has been initiated due to FDAs sample analysis that these needles may core implanted port septums. If you have any questions, call me, Sue Starkey, at 603-357-8733 or via email at astarkey@multimedinc.com.

Device

Device Recall Huber Needle
  • Model / Serial
    Model number 10600218 Lot No 9B020M
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    22ga x 1" Straight Huber Needle || This product is a small gauge needle intended for single use hypodermic access to implanted ports.
  • Manufacturer
    Multi-Med, Inc.

Manufacturer

Multi-Med, Inc.
  • Manufacturer Address
    Multi-Med, Inc., 26 Victoria Ct, Keene NH 03431-4218
  • Manufacturer Parent Company (2017)
    Multi-Med, Inc.
  • Source
    USFDA