Events

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

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
    59952
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0013-2012
  • Date de mise en oeuvre de l'événement
    2011-06-22
  • Date de publication de l'événement
    2011-10-05
  • 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=104065
  • 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
    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)
  • Modèle / numéro de série
    Lot 1C00776 No 510K since this is Class I exempt.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Convatec Inc., 200 Headquarters Park Drive, Skillman NJ 08558-2600
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA