Events

Recall of Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm)

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
    59952
  • Event Risk Class
    Class 3
  • Event Number
    Z-0013-2012
  • Event Initiated Date
    2011-06-22
  • Event Date Posted
    2011-10-05
  • 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=104065
  • 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
    Post-operative kits 57 mm may contain 70 mm pouches.
  • Action
    The firm, ConvaTec, sent a "MEDICAL DEVICE RECALL" letter dated June 22, 2011 via UPS 2nd day air to all customers and sales representatives that received product. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop distributing and quarantine the recalled lot; perform a count of recalled product currently in inventory; complete and return the Recall Response Form via fax to (908) 904-2120 or mail to 200 Headquarters Park Drive, Skillman, New Jersey 08558; return the Recall Response Form even if no recalled product is in inventory; call the toll free number 1-800-582-6514 for return instructions and RGA number-(recall product must be returned in a separate container from any other product returns); mark all return shipments "Recalled Product" and provide supplied RGA number, and forward this letter to customers, if they distributed the product. Should you have any questions, call 1-800-582-6514.

Device

Device Recall Natura Durahesive ConvaTec Moldable Technology PostOperative /Surgical System (57 mm)
  • Model / Serial
    Lot 1C00776 No 510K since this is Class I exempt.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX and UT.
  • Product Description
    Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) || 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