Events

Rappel de Device Recall MoblVac Portable Wound Care Pump

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
    55638
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1777-2010
  • Date de mise en oeuvre de l'événement
    2010-05-10
  • Date de publication de l'événement
    2010-06-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91381
  • 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
    Pump, portable, aspiration (manual or powered) - Product Code BTA
  • Cause
    Ohio medical has received a report of an explosive event with a moblvac portable woundcare pump housing where parts were separated while in an enclosed nylon transport bag during use.
  • Action
    Ohio Medical sent Urgent Medical Device Recall letters dated 5/7/10 to the direct accounts on 5/10/10, with follow-up telephone calls on 5/11/10. The accounts were informed of the one report of an explosion of the pump, and were requested to take the pumps out of service and return the pumps to Ohio Medical. The accounts were requested to complete and fax back to Ohio Medical the enclosed acknowledgement form indicating the number of pumps being returned. Any questions were directed to Anita Christ at 847-855-6270. Follow-up letters dated 5/13/10 were sent to the accounts on 5/14/10, providing instructions for the return of the pumps and bags. Shipping boxes will be sent to the accounts based on the number of pumps reported on the acknowledgment form.

Device

Device Recall MoblVac Portable Wound Care Pump
  • Modèle / numéro de série
    Serial numbers NPJ0001 through NPJ0348 and NPK0001 through NPK0095.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Qatar and Oman
  • Description du dispositif
    MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental, 769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales unit with case).
  • Manufacturer
    Ohio Medical Corporation

Manufacturer

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