Events

Recall of SURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar

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
    78507
  • Event Risk Class
    Class 2
  • Event Number
    Z-0525-2018
  • Event Initiated Date
    2017-10-26
  • 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=159675
  • 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
    Ostomy care kit - Product Code PQE
  • Reason
    A portion of lot 7h02242 outer boxes (market units) of the sur-fit natura moldable durahesive skin barrier (10 pack, 45 mm, ref 411802) were incorrectly labeled as natura moldable stomahesive skin barrier (10 pack, 45 mm, ref 411803).
  • Action
    Customers were notified of the recall via Urgent: Voluntary Medical Device Recall letters on approximately 10/26/2017. The letter identified the affected device and the reason for the recall. The letter also provided instructions for distributors, retailers, and end users. End Users are to 1.) Inspect all shippers of 411802 (Durahesive), and all loose market units of 411803 (Stomahesive) to confirm whether affected product is under their control; 2.) Perform a count of affected product currently in inventory and complete and return the enclosed response form to the address provided; 3.) If customers have any affected product in inventory they are to contact cic@convatec.com or call the Customer Interaction Center at the toll free number 1-800-422-8811 for further instructions regarding how to return affected product and receive correctly labeled replacement product.

Device

SURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar
  • Model / Serial
    Lot 7H02242
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.
  • Product Description
    SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. || Intended for use as an ostomy protector providing a protective barrier to patient skin.
  • 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