Events

Rappel de Device Recall Bur Hypo Pack

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 Novomedicus Llc.

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
    60844
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0920-2012
  • Date de mise en oeuvre de l'événement
    2011-06-22
  • Date de publication de l'événement
    2012-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106737
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Cause
    On 06/22/2011 novomedicus, fl initiated a recall of the artificial bur hypopack lot 1010.1, 1102.1, 1103.1 and 5643.2. cytotoxicity testing revealed a biocompatibility issue. the test results did not represent a health risk.
  • Action
    Novomedicus sent a Medical Device Correction letter dated June 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy the inventory, or return the inventory to Novomedicus. If customers decided to return the remaining inventory, Novomedicus would provide TWO replacement kits for each one returned at no additional cost. Customers were asked to complete the attached Return Response form and return to NovoMedicus using the self-addressed and stamped envelope included. For questions regarding this recall call 941-375-4108.

Device

Device Recall Bur Hypo Pack
  • Modèle / numéro de série
    Lots: 1010.0, 1102.1, and 1103.1
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Wordwide Distribution - USA including IL, AZ, PA, CT, MO, WI, NY, TX, OR, ME, FL, VA, and MS and the countries of Mexico and Qatar.
  • Description du dispositif
    The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only. || Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Hook Sheet. || 2. 60cm x 85 cm Steri Drape || 3. Drain with Connector || 4. 4 x Gauze Rolls || Sterile: Contents are sterile for maximum two years unless enclosed package has been opened or damaged. || Used for a fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible; to prevent perfusion impairment of abdominal organs from increases intra-abdominal pressure; and for advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
  • Manufacturer
    Novomedicus Llc

Manufacturer

Novomedicus Llc
  • Adresse du fabricant
    Novomedicus Llc, 990 Gulf Winds Way, Nokomis FL 34275-3363
  • Source
    USFDA