Events

Rappel de Vacuum Collection Bottle

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 Ohio Medical Corporation.

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
    53192
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0090-2010
  • Date de mise en oeuvre de l'événement
    2009-09-21
  • Date de publication de l'événement
    2009-10-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84897
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Cause
    The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. the recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
  • Action
    Ohio Medical Corporation issued recall letters beginning September 17, 2009. Consignees were informed of the affected product and requested to return affected collection bottles to the firm. The accounts were requested to complete and return the enclosed acknowledgement form, indicating the number of affected units on hand, to obtain a returned material authorization for the return of the recalled bottles and their replacement. For further information, contact Ohio Medical Quality Assurance Manager, Anita Christ, at 847-855-6270.

Device

Vacuum Collection Bottle
  • Modèle / numéro de série
    The bottles are coded with a date stamp on the bottom of the bottle. The affected code is an "E" inside of a circle.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Chile, Costa Rica, Cyprus, Egypt, El Salvador, Greece, Hong Kong, India, Israel, Japan, Jordan, Korea, Kuwait, Malaysia, Netherlands, Oman, Paraguay, Philippines, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Kingdom and Venezuela.
  • Description du dispositif
    Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: || 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float; || 6700-0018-800 - Bottle with V Wall Bracket, Cap & Float; || 6700-0370-800 - Bottle with Floor Bracket, Cap & Float. || The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids.
  • Manufacturer
    Ohio Medical Corporation

Manufacturer

Ohio Medical Corporation
  • Adresse du fabricant
    Ohio Medical Corporation, 1111 Lakeside Dr, Gurnee IL 60031
  • Source
    USFDA