Events

Recall of ActiveLife OnePiece Drainable Pouch 32mm

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
    56789
  • Event Risk Class
    Class 3
  • Event Number
    Z-0073-2011
  • Event Initiated Date
    2010-09-17
  • Event Date Posted
    2010-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94521
  • 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
    Pouch, colostomy - Product Code EZQ
  • Reason
    Mislabeled: the market units were incorrectly labeled as # 125339 activelife drainable pouch 25 mm; the product inside was actually activelife pouch small tan 32 mm, icc # 125333.
  • Action
    ConvaTec, Inc. sent a Returned Goods Authorization form by e-mail dated September 3, 2010, to one customer. The form identified the product, the problem, and the action the customer should take. The customer was instructed to detach the label and affix it to the outside of the box, copy the RGA # and retain a copy for their records, enclose the completed form and return with the product, For questions call (908) 904-2675.

Device

ActiveLife OnePiece Drainable Pouch 32mm
  • Model / Serial
    Product order number: 125333, Lot number: 0G01881
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA, including IL
  • Product Description
    ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; || 1 1/4 in., 32mm; || Made in Dominican Republic; || ConvaTec. || Colostomy pouch
  • Manufacturer
    Convatec Inc.

Manufacturer

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