Events

Recall of Device Recall Children's Medical Ventures 1 ml Amber Oral Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Benlan, 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
    60828
  • Event Risk Class
    Class 3
  • Event Number
    Z-1070-2012
  • Event Initiated Date
    2011-12-12
  • Event Date Posted
    2012-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107356
  • 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
    Dispenser, liquid medication - Product Code KYX
  • Reason
    The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.
  • Action
    The firm initiated their recall of the specified lots of product in November, 2011 by sending a "Customer/Distributor Medical Device Correction" letter to their consignee. The letter requested they examine their inventory, quarantine any affected product and complete a verification and response form to be returned to the firm. Questions were directed to (905) 829-5004 ext 233.

Device

Device Recall Children's Medical Ventures 1 ml Amber Oral Syringe
  • Model / Serial
    Catalog number 1047080 - lot numbers 076192, 076404, 076904, 077695, 078697, 079540 and 079686.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, USA - including only the state of Pennsylvania
  • Product Description
    Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser.
  • Manufacturer
    Benlan, Inc.

Manufacturer

Benlan, Inc.
  • Manufacturer Address
    Benlan, Inc., 2760 Brighton Road, Oakville Canada
  • Source
    USFDA