Events

Rappel de Device Recall Regard Custom Surgical Pack

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 Resource Optimization & Innovation 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
    72053
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0229-2016
  • Date de mise en oeuvre de l'événement
    2015-08-25
  • Date de publication de l'événement
    2015-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139676
  • 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
    General surgery tray (kit) - Product Code LRO
  • Cause
    The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated iv set.
  • Action
    ROi sent a Notice of Correction/Removal letter dated August 25, 2015, to all affected customers. The letter notified customers that ROi recently received notice of a voluntary recall from Edwards Lifesciences regarding their Transducer Kit. ROi also sent an email to their customer on September 25, 2015, informing them of the recall. Attached to the email was the component manufacturer's recall notice and a recall notice from the recalling firm. The recalling firm's recall notice instructed their customer to respond to the notice indicating whether they had any of the recalled product remaining and to destroy any remaining product in their inventory. For questions regarding this recall call 417-820-2793.

Device

Device Recall Regard Custom Surgical Pack
  • Modèle / numéro de série
    Lot 25787E, exp. date 1/19/2017
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to one customer in Oklahoma.
  • Description du dispositif
    Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
  • Manufacturer
    Resource Optimization & Innovation Llc

Manufacturer

Resource Optimization & Innovation Llc
  • Adresse du fabricant
    Resource Optimization & Innovation Llc, 2909 N Neergard Ave, Springfield MO 65803
  • Source
    USFDA