Events

Recall of Device Recall Nutrisafe 2 Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Churchill Medical Systems, 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
    54481
  • Event Risk Class
    Class 3
  • Event Number
    Z-1203-2010
  • Event Initiated Date
    2010-01-29
  • Event Date Posted
    2010-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88562
  • 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
    Tubes, Gastrointestinal (And Accessories) - Product Code KNT
  • Reason
    Mislabeled feeding syringes : 6 ml syringe mislabeled as 5 ml.
  • Action
    Churchill Medical issued an Urgent: Product Advisory Customer Notification on January 29, 2010 to customers and distributors via overnight delivery. The letter identified the affected product along with the corresponding lot numbers and explained the problem. Accounts are requested to complete the enclosed form and fax it to 215-672-6740, attention Marie Benson. The affected products should be quarantined and customer service should be contacted to arrange return of product. Questions should be directed to Marie Benson at 800-473-5414.

Device

Device Recall Nutrisafe 2 Syringe
  • Model / Serial
    Lot Numbers: 910118 Exp: 2014/10
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.
  • Product Description
    Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 || Product Code: 1015.062M || Vygon/Churchill Medical System
  • Manufacturer
    Churchill Medical Systems, Inc.

Manufacturer

Churchill Medical Systems, Inc.