Events

Recall of Device Recall ActiveLife

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
    36268
  • Event Risk Class
    Class 3
  • Event Number
    Z-1532-06
  • Event Initiated Date
    2006-07-31
  • Event Date Posted
    2006-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48278
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    ostomy pouch - Product Code LNO
  • Reason
    Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.
  • Action
    A recall notification was mailed by first class mail on 7/31/2006 to all direct customers with letter to tier 1 distributors for tier 2 end users.

Device

Device Recall ActiveLife
  • Model / Serial
    REF 413145; UPC 0034 13145 Lot #6E3589N
  • Product Classification
    Gastroenterology-Urology Devices
  • Distribution
    Nationwide
  • Product Description
    ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) || 1 3/4 in. 45 mm
  • Manufacturer
    ConvaTec

Manufacturer

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