Events

Rappel de MOST

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 Pacific Consolidated Industries 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
    49030
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2201-2008
  • Date de mise en oeuvre de l'événement
    2007-09-08
  • Date de publication de l'événement
    2008-08-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72552
  • 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
    mobile oxygen storage tank - Product Code CAW
  • Cause
    The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges. with one unit the operator was able to shut off the oxygen flow, however one rupture resulted in a fire. no injuries were reported.
  • Action
    PCI sent a Recall Notification letter to the Spanish Air Force September 8, 2007. The Recall Notification letter was mailed to the US Defense Supply Center on July 24, 2008 after a recall agreement was signed on July 8, 2008 between Pacific Consolidated Industries and the Defense Supply Center. The recall notification to Spanish Air Force informed the consignee of the problem and asked the consignee to remove the affected units from service until a Technical Service Representative could be sent to Spain to inspect the affected units and perform the corrective action. The recall notification to Defense Supply Center instructed the consignee to keep the affected units in quarantine (units placed in quarantine by US Air Force August 3, 2007) until they have been refurbished under recall agreement that was signed on July 8, 2008.

Device

MOST
  • Modèle / numéro de série
    Serial numbers: 6947-001 to 6947-546, 6968-001 to 6968-211, 6982-001 to 6982-134, C4340-24, C4340-25, 7224-001 to 7224-011, and 10001 to 10194.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide to US Air Force and also to Spain
  • Description du dispositif
    Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002
  • Manufacturer
    Pacific Consolidated Industries LLC

Manufacturer

Pacific Consolidated Industries LLC
  • Adresse du fabricant
    Pacific Consolidated Industries LLC, 12201 Magnolia Ave, Riverside CA 92503-4820
  • Société-mère du fabricant (2017)
    Pacific Consolidated Industries Llc
  • Source
    USFDA