Events

Rappel de Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits

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. Lafollette.

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
    59854
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0015-2012
  • Date de mise en oeuvre de l'événement
    2011-08-23
  • Date de publication de l'événement
    2011-10-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103871
  • 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
    Anesthesia breathing circuit kit (adult & pediatric) - Product Code OGD
  • Cause
    The firm manufactured kits containing a hch device, manufactured by vital signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.
  • Action
    The firm, DeRoyal, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated September 13, 2011 to its customers. The letter describes product, problem, and actions to be taken. Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Distributors were instructed to perform a sub-recall to their customers. Customers with questions should call 865-362-1037 between 9am and 5pm EST or email recalls@deroyal.com.

Device

Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits
  • Modèle / numéro de série
    REF 86-001737, Lot Number 25660996 REF 86-001781, Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 REF 86-001641, Lot Numbers: 25573171, 25765667, 25834853, 25834861 REF 86-001619, Lot Number 25573155 REF 86-001669, Lot Numbers: 25313484, 25702324, 25977977
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.
  • Description du dispositif
    Custom anesthesia kits labeled as follows: || (1) DeRoyal (R) Adult Exp Anesthesia Circuit, REF 86-001737, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Number 25660996 || (2) DeRoyal (R) Adult Anesthesia Circuit, REF 86-001781, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 || (3) DeRoyal (R) Latex Safe Anesthesia Kit, REF 86-001641, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25573171, 25765667, 25834853, 25834861 || (4) DeRoyal (R) Custom Anesthesia Kit, REF 86-001619, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Number 25573155 || (5) DeRoyal (R) Anesthesia Kit, REF 86-001669, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25313484, 25702324, 25977977 || Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
  • Manufacturer
    Deroyal Industries, Inc. Lafollette

Manufacturer

Deroyal Industries, Inc. Lafollette
  • Adresse du fabricant
    Deroyal Industries, Inc. Lafollette, 1501 East Central Ave, La Follette TN 37766-2892
  • Société-mère du fabricant (2017)
    Deroyal Industries Inc.
  • Source
    USFDA