Events

Rappel de DeRoyal Sterile Custom kits

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 DeRoyal Industries 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
    78517
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0199-2018
  • Date de mise en oeuvre de l'événement
    2017-10-16
  • 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=159686
  • 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
    Custom surgical kits contain aplicare povidone iodine prep pads which were subsequently recalled by medline industries for incorrect expiration date.
  • Action
    DeRoyal sent an Urgent Recall Notice letter dated October 17, 2017, to the end-user level. The letter identified the affected product, problem and actions to be taken. Consignees were asked to return any product they held in stock to DeRoyal and to complete the Notice of Return Form indicating what they were returning. Credit will be issued. They were asked to complete and return the Notice of Return Form even if they no longer held any affected product. For questions call 865-362-4203.

Device

DeRoyal Sterile Custom kits
  • Modèle / numéro de série
    a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution in the states of GA, IN, FL, and PA
  • Description du dispositif
    DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: || a) Incision and Drainage Tray, REF 47-763.04 || b) Incision and Drainage Tray, REF 47-763.06 || c) Incision and Drainage Tray, REF 47-763.07 || d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 || e) Incision and Drainage Tray, REF 89-6818.02 || f) Plastic Pack, REF 89-7212.04 || g) Plastic Pack, REF 89-7212.05 || Product Usage: || Custom surgical and procedural kits
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Adresse du fabricant
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Société-mère du fabricant (2017)
    Deroyal Industries Inc.
  • Source
    USFDA