Events

Recall of Device Recall Inrad sample master aspiration biopsy needle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inrad, 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
    57531
  • Event Risk Class
    Class 2
  • Event Number
    Z-1063-2011
  • Event Initiated Date
    2010-12-20
  • Event Date Posted
    2011-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96475
  • 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, aspiration and injection, disposable - Product Code GAA
  • Reason
    This lot of product has the wrong expiration date on the carton label. the pouches contained the correct expiration date.
  • Action
    The firm, Inrad Inc., sent an "URGENT FIELD CORRECTION" notice dated December 20, 2010 to its customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to immediately examine their inventory for the affected product. If the recalled product was in stock, the customers were told to removed the affected product from the carton and dispose of carton; to disregard carton label expiration date and reference the expiration date appearing on the pouch label only, and to complete, sign and return the attached "Carton Expiration Date" INFORMATION FORM via fax to 616-301-779 or mail to Inrad Inc., ATTN: Director RA/QA, 4375 Donker Court SE, Kentwood, MI 49512. If you have any additional questions about this action, please call 800-558-4647 extension 102.

Device

Device Recall Inrad sample master aspiration biopsy needle
  • Model / Serial
    6100-7001.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA including states of: FL, GA, KY, NH, NJ, NM, PA , SC, WA, and WI.
  • Product Description
    Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. || The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.
  • Manufacturer
    Inrad, Inc

Manufacturer

Inrad, Inc
  • Manufacturer Address
    Inrad, Inc, 4375 Donkers Ct Se, Kentwood MI 49512-4054
  • Manufacturer Parent Company (2017)
    Inrad Inc.
  • Source
    USFDA