Events

Rappel de Device Recall Negative Pressure Wound Therapy Powered Suction 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 Accuro Medical Product 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
    63064
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0009-2013
  • Date de mise en oeuvre de l'événement
    2012-08-31
  • Date de publication de l'événement
    2012-10-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112429
  • 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
    Wound Pro Apex Negative Pressure Wound Therapy - Product Code OMP
  • Cause
    Accuro has received reports of some apex pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.
  • Action
    The firm, Accuro, sent an "Urgent: Medical Device Recall" letter dated August 30, 2012 to the customers via e-mail on August 31, 2012. The letter describes the product, problem and actions to be taken. The customers were instructed to remove all devices from use immediately; to immediately complete and return the enclosed Accuro response form via email to; (customer.service@accuromedical.com) or fax to: (1-800-866-0545) . Note: the form still needs to be returned even if you no longer have or use the device. Upon receipt, Customer Service will call the account with instructions to arrange for all devices to be returned to Accuro. General questions were directed to Customer Service at 1-800-669-4757.

Device

Device Recall Negative Pressure Wound Therapy Powered Suction Pump
  • Modèle / numéro de série
    part number 84635400182, serial numbers E000146 through E002039, (all serial numbers)
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • Description du dispositif
    Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 || Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
  • Manufacturer
    Accuro Medical Product LLC

Manufacturer

Accuro Medical Product LLC
  • Adresse du fabricant
    Accuro Medical Product LLC, 2854 Hitchcock Ave, Downers Grove IL 60515-4016
  • Société-mère du fabricant (2017)
    Accuro Medical Products Llc
  • Source
    USFDA