Events

Recall of Device Recall GentleTouch System Postoperative Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConvaTec.

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
    47210
  • Event Risk Class
    Class 3
  • Event Number
    Z-1314-2008
  • Event Initiated Date
    2008-03-07
  • Event Date Posted
    2008-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69037
  • 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
    Ostomy pouch and accessories - Product Code EXB
  • Reason
    Mislabeled: the carton label reads "for postsurgical use following a urostomy procedure." it should read "for postsurgical use following a colostomy or ileostomy procedure.".
  • Action
    Consignees were notified by an Urgent Product Recall letter sent on 3/7/08. The letter instructed users to return any unused affected product to the recalling firm for a credit. For additional information, contact 1-800-422-8811.

Device

Device Recall GentleTouch System Postoperative Kit
  • Model / Serial
    Lot Numbers: 7G29699, 7G30740, 7G31418, 7H22693, 7H24608, 7J30626, 7J32192 and 7K30871. Lot numbers 7L27391, 8A33519 and 8A37099 are also affected, however they have not been distirbuted.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and country of Canada.
  • Product Description
    GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 08558.
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • Manufacturer Address
    ConvaTec, 200 Headquarters Park Dr, Skillman NJ 08558-2624
  • Source
    USFDA