Events

Rappel de 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
    78377
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0169-2018
  • 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=159384
  • 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 - Product Code LRO
  • Cause
    Resource optimization & innovation, llc (roi) received a recall notice from bd for an incorrect label on 3ml chloraprep with tint, product code (ref) 260415ns, ndc 054365-400-11, lot 7096622. the label mix is at the unit level where a "chloraprep one-step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "chloraprep with tint" label. the recall notification was issued by bd on september 15, 2017 and was received by roi on september 18, 2017. because the 3ml chloraprep with tint product is contained within select roi regard custom surgical packs, roi is conducting a recall of the affected roi regard custom surgical packs.
  • Action
    Customer was notified of the recall via email on September 25, 2017. Instructions included identify and quarantine any affected products, notify ROi by completing and returning the completed notification form, coordinating the issuance of supplemental labeling which will instruct the end user to remove and discard the recalled ChloraPrep at the time of use. For further questions, please call (417) 820-2793

Device

Regard Custom Surgical Pack
  • Modèle / numéro de série
    Item No. 800620003, Lot No. 047005C, Exp. Date 08/15/2019
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed domestically to Texas.
  • Description du dispositif
    Regard Custom Surgical Pack || Packs 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 65803-6317
  • Source
    USFDA