Events

Recall of Device Recall ConvaTec

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Convatec 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
    65879
  • Event Risk Class
    Class 3
  • Event Number
    Z-1991-2013
  • Event Initiated Date
    2013-06-25
  • Event Date Posted
    2013-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120670
  • 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
    Convatec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of flexi-seal signal fms. in certain lots, the lot number convention was duplicated on the packaging.
  • Action
    ConvaTec issued a notification letters to their customers dated June 25, 2013 via UPS. The letter informed the customer of the issue with the related product and the action to be taken. If the customer has any question regarding the notification they can contact customer service at 1-800-422-8811.

Device

Device Recall ConvaTec
  • Model / Serial
    Flexi-Seal Signal + ICC Code 418000; SAP Code# 1705108, Lots 12-FM-01 and 12-FM-02.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    ConvaTec Flexi-Seal SIGNAL +, Rx Only || Product Usage: || For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
  • Manufacturer
    Convatec Inc.

Manufacturer

Convatec Inc.
  • Manufacturer Address
    Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA