Events

Rappel de PURE OXYGEN CONCENTRATOR, CHAD Drive

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 Inovo, 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
    78883
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0407-2018
  • Date de mise en oeuvre de l'événement
    2017-10-09
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160803
  • 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
    Generator, oxygen, portable - Product Code CAW
  • Cause
    Post-market surveillance for pure stationary oxygen concentrators model chsooo and chsooos demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
  • Action
    The firm initiated their recall by letter on 10/09/2017. The letter stated the following: "Actions to be Taken: Based on our distribution records, your firm has received one or more Pure Stationary Oxygen Concentrators. We respectfully request that you take the following actions: 1. Contact all patients and customers that currently have Pure Stationary Oxygen Concentrators in their homes or facilities and inform them of this recall. Retrieve the oxygen concentrators from their homes or facilities. 2. Destroy all Pure Stationary Oxygen Concentrator(s) in accordance with the following steps: a. Assure that the unit is not plugged into an electrical outlet. b. Cut the power cord of each oxygen concentrator. c. Take a digital photo of each oxygen concentrator that depicts both the power cord and the serial number of the depicted unit. Note that the serial number is located on a label on the back of the unit. d. Dispose of the oxygen concentrator in accordance with local ordinances. e. Record the serial number of each unit that is destroyed, sign and date the enclosed Recall Return Response Card. 3. Email or fax the completed response form and photos documenting destruction to: Email: lnovo4209@stericycle.com Fax: 1-877-497-2559 4. Sales of the Pure Stationary Oxygen Concentrator have been discontinued. Pure Stationary Oxygen Concentrators which have been destroyed will be replaced with a DeVilbiss 525DS Oxygen Concentrator in order to minimize any interruption in patient's supplemental oxygen therapy. 5. Pure Concentrators that have been returned to lnovo for repair will not be returned and will be replaced with a DeVilbiss 525DS Oxygen Concentrator. Other Information: Should you require any additional information about this recall action, please call 1-888-679-5132, Monday-Friday 8am-Spm Eastern."

Device

PURE OXYGEN CONCENTRATOR, CHAD Drive
  • Modèle / numéro de série
    UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    worldwide
  • Description du dispositif
    PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
  • Manufacturer
    Inovo, Inc

Manufacturer

Inovo, Inc
  • Adresse du fabricant
    Inovo, Inc, 401 Leonard Blvd N, Lehigh Acres FL 33971-6302
  • Société-mère du fabricant (2017)
    Medical Depot Inc.
  • Source
    USFDA