Events

Recall of Device Recall MEDRX Pediatric Feeding Tube

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
    72851
  • Event Risk Class
    Class 2
  • Event Number
    Z-0595-2016
  • Event Initiated Date
    2015-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142354
  • 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
    Tube, feeding - Product Code FPD
  • Reason
    The product may be packaged with a 5 or 6.5fr tube instead of an 8fr size.
  • Action
    Benlan, Inc. sent a Product Recall Notification letter dated December 11, 2015, to all affected customers. Customers were asked to examine their stock and to discontinue/use of the product and return product. The letter included a response form which was to be returned via fax to 905-825-9600. Customers with questions were instructed to call 905-825-9300.

Device

Device Recall MEDRX Pediatric Feeding Tube
  • Model / Serial
    Lots 114842, 116433 & 118251
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including GA & Internationally to Canada.
  • Product Description
    MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
  • Manufacturer
    Benlan, Inc.

Manufacturer

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