Events

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

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
    57936
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1610-2011
  • Date de mise en oeuvre de l'événement
    2011-02-01
  • Date de publication de l'événement
    2011-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97782
  • 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
    Collector, ostomy - Product Code EXB
  • Cause
    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)
  • Modèle / numéro de série
    Product Code # 416921; Product Lot # 0J00814
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, IL, KS, MA, MI, NC, OK, OR, PA, SC, and TX.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Convatec Inc., 200 Headquarters Park Drive, Skillman NJ 08558-2600
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA