Retiro De Equipo (Recall) de Device Recall Cohesive bandages, CBN1104

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Owens & Minor Distribution, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Tape and bandage, adhesive - Product Code KGX
  • Causa
    Medichoice sterile cohesive bandages imported and sold under a private brand by owens & minor were tested and found to have microbial contamination.
  • Acción
    The firms recall strategy is as follows : recall was initiated by the Owens & Minor Home Office Recall Officer. The Home Office Recall Officer e-mailed the following documents to the Distribution Center (DC) Recall Officer at each affected DC: 1. DC Recall Letter (specific instructions for the DCs), 2. Recall Inventory Report form (for the DCs to record the amount of affected product quarantined), 3. Customer Letter (specific instructions for the customers), 4. Recall Return Response Form (for the customers to report back the details of the quantity of affected product in their inventory), 5. Attachment 1 (a document that provides examples of the product labeling), 6. Recall Checklist (a checklist for the DCs listing the actions that need to be completed), and 7. Recall Combine Queries spreadsheet (listing customers and current on-hand inventory at the DCs). The DC Recall Officer at each DC forwarded the information to the DC Customer Service team. The DC Customer Service team notified each impacted customer via e-mail or letter based upon the customers recorded preference. Level to which the recall was initiated: The recall was initiated to the level of the customer (i.e., hospitals, clinics, surgery centers). Follow-up plans: A minimum of three (3) attempts are made to obtain an acknowledgment from the customer that they received the recall notification. An attempt to determine the status of non-responsive businesses will be made. If the non-responsive business is still viable, an attempt will be made to determine the employee responsible for management of recalls and the recall notice will be sent to that employee. If the business is no longer viable, the steps described below for out-of-business accounts will be followed. Sub-recall: No sub-recall is required. These products are supplied to User Facilities and not distributed to commercial sub-accounts. Plans for effective checks: 1. Check records to ensure that the initial recall not


  • Modelo / Serial
    Item No. Lot No. Expiration Date: CBN1104 15023H09A Jan-18, CBN1104 15033H09A Feb-18, CBN1104 15043H09A Mar-18, CBN1104 15053H09A Apr-18, CBN1104 15063H09A May-18, CBN1104 15073H09A Jun-18, CBN1104 15083H09A Jul-18, CBN1104 14113H09A Oct-17, CBN1104 14123H09A Nov-17, CBN1104 15013H09A Dec-17, CBN1104 14063H09A May-17, CBN1104 14083H09A Jul-17, CBN1104 14093H09A Aug-17, CBN1104 14053H09A Apr-17, CBN1104 14043H09A Mar-17, CBN1104 14013H09A Dec-16, CBN1104 13053H09A Apr-16, CBN1104 12113H09A Oct-15, CBN1104 13033H09A Feb-16, CBN1104 13083H09A Jul-16, CBN1104 13083H09A Jul-16, CBN1104 13103H09A Sep-16, CBN1104 13113H09A Oct-16, CBN1104 13123H09A Nov-16.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] || General Hospital Use.
  • Manufacturer


  • Dirección del fabricante
    Owens & Minor Distribution, Inc., 9120 Lockwood Blvd, Mechanicsville VA 23116-2015
  • Empresa matriz del fabricante (2017)
  • Source