Events

Rappel de Device Recall GEOMED CABG PACK PGYBK A & B

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
    79052
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0637-2018
  • Date de mise en oeuvre de l'événement
    2018-01-22
  • 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=161247
  • 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
    Deroyal manufactured custom sterile surgical kits containing the terumo over pressure safety valve, which were subsequently recalled by terumo cvs due to reports of 'no flow' through the ops valve.
  • Action
    The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 01/22/18 to its Consignees on 1/22/18 by overnight mail. The firm sent a follow-up "URGENT! RECALL NOTICE" letter dated 1/29/18. The letters described the product, problem and actions to be taken. The Consignees were instructed to identify affected products; place in quarantine; complete and return the Notice of Return Form, even if they no longer held any affected product, to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 3/1/18, and return any product they held in stock. If you have further distributed these products, notify your customers of this recall. If you have questions or need assistance with the recall, please contact Regulatory Recall Coordinator and Quality Projects Manager at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com.

Device

Device Recall GEOMED CABG PACK PGYBK A & B
  • Modèle / numéro de série
    Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to: NY
  • Description du dispositif
    Custom sterile surgical packs labeled as follows: || GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO || Use: Shoulder Arthroscopy
  • 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