Events

Rappel de Solus Flexible wirereinforced laryngeal mask

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 Intersurgical 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
    76945
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0208-2018
  • Date de mise en oeuvre de l'événement
    2017-04-03
  • 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=154650
  • 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
    Mask, oxygen - Product Code BYG
  • Cause
    A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
  • Action
    Intersurgical sent an Urgent Medical Device Recall Notice dated April 3rd, 2017, along with response forms to Customers. Customers were advised to immediately discontinue use and quarantine affected products. If affected products were further distributed, customers are advised to notify those individuals and advise them of the recall situation and have them return their outstanding stock to you. Customers with questions can call the IS Customer Service line at 800-828-9633 for a Return Authorization Number. Once customers receive the Return Authorization Number, please enter it in the space provided on the Recall Response Form. The completed Recall Response Form should be emailed to: Support@intersurgicalinc.com For further questions, please call (315) 451-2900)

Device

Solus Flexible wirereinforced laryngeal mask
  • Modèle / numéro de série
    Product Lots: 31402822 to 31610791
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
  • Description du dispositif
    Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 || Patent airway management.
  • Manufacturer
    Intersurgical Inc

Manufacturer

Intersurgical Inc
  • Adresse du fabricant
    Intersurgical Inc, 6757 Kinne St., E. Syracuse NY 13057
  • Société-mère du fabricant (2017)
    Intersurgical Incorporated
  • Source
    USFDA