Events

Retiro De Equipo (Recall) de Custom Procedure Trays, containing various configurations of medical and surgical devices, packed in plastic pouches, labeled in part ***Avid Medical, The custom procedure tray company Toano, Virginia 23168***Sterile~Disposable~Single Use Only***

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 Avid Medical 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
    Recall
  • ID del evento
    33335
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1398-05
  • Fecha de inicio del evento
    2005-09-09
  • Fecha de publicación del evento
    2005-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41711
  • 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
    General Surgery Tray - Product Code LRO
  • Causa
    Defect in packaging of medical devices may compromise sterility of these products used in medical and surgical procedures.
  • Acción
    The recalling firm notified distributors and end users by letter 09/07/05. The notification advised of product packaging in which seal integrity may have been compomised. The recall letter lists specific lots and item numbers of the custom trays to be returned for replacement or reimbursement. A response form is included in the notification.

Device

Custom Procedure Trays, containing various configurations of medical and surgical devices, packe...
  • Modelo / Serial
    Lots: 385569 386370 388085 380910 385604 386873 386153 388558 387906 386224 385726 386714 386721 386142 387590 386731 386732 386337 385262 386756 383386 383385 385819 386706 385980 386074 386472 385660 386649 386409 384525 386543 386410 385493 386849 385945 387453 386357 388777 385542
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was sold to distributors and end user medical facilities nationwide.
  • Descripción del producto
    Custom Procedure Trays, containing various configurations of medical and surgical devices, packed in plastic pouches, labeled in part ***Avid Medical, The custom procedure tray company Toano, Virginia 23168***Sterile~Disposable~Single Use Only***, and further identified by the following catalog numbers: || BOOZ001-01 CATARACT PACK*** || VMLR0009-05 FEM POP*** || AZSS001-01 SINGLE SHOT EPIDURAL TRAY*** || META026-01 SHOULDER*** || MPOC002-02 ARTHROSCOPY PACK*** || MMMC002 UNIVERSAL ARTHROSCOPY PACK*** || ORHS023-03 OBSTETRICAL PACK W/POUCH*** || MSCB002-02 BASIC PACK*** || ADVH002-08 OPEN HEART KLICH PACK*** || ADVM005-02 PACEMAKER-IL MASONIC*** || CILS004-03 EXTREMITY PACK*** || NOIN004 ARTHROGRAM PACK*** || RMRI036-11 TOTAL JOINT PACK*** || NRSC0003-06 ARTHROSCOPY PACK*** || AV10584-03 COMMUNITY RETINAL DETACHMENT*** || STJN030-02 HEART DRAPE TRAY*** || STJN045 HEART OFF PUMP*** || PHLS008-04 SPECIAL PROCEDURES PACK*** || UHSN035-02 TOTAL KNEE*** || SLIZ004a-02 CATH TRAY*** || NYOD008 Abdominal Preservation Kit*** || NYOD011 PEDIATRIC ABDOMINAL*** || FAMC017-05 MAJOR BASIN SET*** || AGAK005-04 BASIN SET-SURGERY CENTER*** || AV010773-02 C-SECTION PACK*** || OSUM018-04 OPHTHALMOLOGY CUSTOM TRAY*** || KENT005-01 CAROTID*** || HVCCA-10 HEART PACK*** || SUMM004-04 Harris Basic*** || MCVA0020-07 BUNDLE, EYE*** || MCVA0025-04 BUNDLE, LOWER EXTREMITY*** || MCVA0033-06 PDS, MAJOR EAR*** || MCVA0039-06 PDS, TOTAL KNEE*** || MCVA0044-02 PACEMAKER PACK*** || NAPO0014-04 LAP CHOLE CUSTOM TRAY*** || NAPO0025-05 HAND & PODIATRY TRAY*** || NAPO0061-02 ABDOMINOPLASTY CUSTOM TRAY*** || LIFE0027-06 C.V. TRANSPORT BOX*** || WIAS002-01 UNIVERSAL BLOCK TRAY*** || UMCW013-07 TOTAL KNEE PDS***
  • Manufacturer
    Avid Medical Inc

Manufacturer

Avid Medical Inc
  • Dirección del fabricante
    Avid Medical Inc, 9000 Westmont Drive, Stonehouse Commerce Park, Toano VA 23168
  • Source
    USFDA