Events

Recall of Device Recall Natura Durahesive Convatec Moldable Techonology PostOperative/Surgical System (57mm)

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
    57936
  • Event Risk Class
    Class 3
  • Event Number
    Z-1610-2011
  • Event Initiated Date
    2011-02-01
  • Event Date Posted
    2011-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97782
  • 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
    Collector, ostomy - Product Code EXB
  • Reason
    Natura durahesive convatec moldable technology post operative/surgical system (57mm) units may contain pouches with 45 mm natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together.
  • Action
    Convatec sent a Medical Device Recall letter dated February 1, 2011, via UPS with return response forms attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop distributing and quarantine the recalled lot (0100814). Perform a count of recalled product currently in inventory. Complete the enclosed Recall Response Form and return it to the address on the response form. Return the attached Recall Response Form even if no recalled product is in inventory. Ensure that their account number is correctly identified on the attached Recall Response Form. To return the recalled product call the toll free number 1-800-582-6514 to receive an RGA number and instructions on how and where to return the recalled product. If the product has been distributed to wholesalers then customers should forward the letter to them and ask that they follow the Required Actions and return the Recall Response Form to the address listed on the form. Product must be labeled for shipment to: UPS Supply Chain Solutions 1920 Outer Loop Dock Door #123 Louisville, KY 40219 For questions regarding this recall call 908-904-2149.

Device

Device Recall Natura Durahesive Convatec Moldable Techonology PostOperative/Surgical System (57mm)
  • Model / Serial
    Product Code # 416921; Product Lot # 0J00814
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, IL, KS, MA, MI, NC, OK, OR, PA, SC, and TX.
  • Product Description
    Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch || This kit is comprised of a pouch, wafer, and related accessories (low pressure adaptor, measuring guide, insert and other packaging components); required for application to a patient immediately after ostomy surgery.
  • 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