Events

Recall of Convatec Esteem(TM) Synergy Stomahesive(R),

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
    79953
  • Event Risk Class
    Class 2
  • Event Number
    Z-1890-2018
  • Event Initiated Date
    2018-04-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164023
  • 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
    Blood Establishment Computer Software and Accessories - Product Code MMH
  • Reason
    It was discovered that the stoma hole of one lots of the esteem synergy stomahesive skin barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
  • Action
    ConvaTec sent an Urgent Voluntary Medical Device Recall dated April 20, 2018. Customers were directed to inspect their inventory, perform a count of affected product, and respond even if none of the recalled product was found. Once the response is received, return instructions will be provided. Distributors were directed to perform a sub-account recall, forwarding the letter to their customers. The firm will be providing replacement product.

Device

Convatec Esteem(TM) Synergy Stomahesive(R),
  • Model / Serial
    Lot Number 7F00987
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 || Product Usage: || Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
  • Manufacturer
    ConvaTec, Inc

Manufacturer

ConvaTec, Inc
  • Manufacturer Address
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA