Events

Rappel de Device Recall Hospilak, Portex First Breath, MediChoice

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
    57626
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1255-2011
  • Date de mise en oeuvre de l'événement
    2011-01-07
  • Date de publication de l'événement
    2011-02-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96883
  • 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
    oxygen mask - Product Code BYL
  • Cause
    Face tents and oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate.
  • Action
    Unomedical, Inc issued recall letters with attached return response forms dated January 7, 2011 via UPS. The letters request the customer stop use and quarantine product. The recall response form is to be completed and returned to Unomedical. The letters/return response form were also sent out in Spanish. Another recall letter was sent dated February 16, 2011 to capture additional lots that werent included in the initial letter.

Device

Device Recall Hospilak, Portex First Breath, MediChoice
  • Modèle / numéro de série
    Numerous lots produced between June 2009 and September 2010.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden and Switzerland, Israel, Jordan, Lebanon, Libya, Morocco, Saudi Arabia, United Arab Emirates, Russia, Australia, New Zealand, Japan and Vietnam.
  • Description du dispositif
    Face Tent || Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. || Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Manufactured for Unomedical inc. || Hospilak Ref. No. 115-E, Face Tent, Adult 5 (1.5m) Tubing Manufactured for Unomedical inc. || Hospilak Ref. No. 116-E, Face Tent, Adult 6 (1.8 m) Aerosol Tubing Manufactured for Unomedical inc. || McKesson Aerosol Mask, Face Tent Adult, No Tubing Reorder No. 86-110E || Face Tent Adult, 6 (1.8m) Aerosol Tubing Reorder no. 86-116E || Smiths Medical Portex First Breath Adult Face Tent (Non-latex) Ref 001490 || Smiths Medical Portex First Breath Adult Face Tent with Tubing, 188cm (5 ft.) (Non-latex) Ref 001492 || Owens & Minor MediChoice Adult Face Tent Re-Order #RSP3000 and Face Tent, Adult 6 (1.8m) Aerosol Tubing Re-Order #RSP3060
  • 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