Events

Rappel de SURFIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par ConvaTec, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78507
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0525-2018
  • Date de mise en oeuvre de l'événement
    2017-10-26
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159675
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Ostomy care kit - Product Code PQE
  • Cause
    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
  • Modèle / numéro de série
    Lot 7H02242
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA