Events

Rappel de Device Recall STATCheck MANUAL RESUSCITATOR / VENTILATOR

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 Sun Med, 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
    80201
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2145-2018
  • Date de mise en oeuvre de l'événement
    2018-05-24
  • 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=164843
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • Cause
    There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
  • Action
    On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions: 1) Examine inventory, quarantine and cease distribution of impacted product. 2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed. 3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible. 4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly. Customers with questions can call 1-800-433-2797 or email info@sun-med.com

Device

Device Recall STATCheck MANUAL RESUSCITATOR / VENTILATOR
  • Modèle / numéro de série
    Lot Numbers: 313406, 313447, 313164, 313165 & 313166
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    IL & OH distributors
  • Description du dispositif
    STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
  • Manufacturer
    Sun Med, LLC

Manufacturer

Sun Med, LLC
  • Adresse du fabricant
    Sun Med, LLC, 2710 Northridge Dr NW Ste A, Grand Rapids MI 49544-9112
  • Source
    USFDA