Events

Retiro De Equipo (Recall) de Device Recall Customed

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 Customed, 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
    68536
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2342-2014
  • Fecha de inicio del evento
    2014-05-20
  • Fecha de publicación del evento
    2014-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129236
  • 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
    Obstetrical kit - Product Code OKV
  • Causa
    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Acción
    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Device

Device Recall Customed
  • Modelo / Serial
    Product code 900-645, 51 lots: 109030612 109030699 109051050 109051212 110061464 110071705 110081981 110082075 110092405 110112816 110122898 111010147 111020295 111030648 111041071 111051300 111061559 111071831 111092556 111102774 111112951 111112964 111123280 112010194 112010255 112030736 112052003 112083214 112093731 112104256 112114396 112125106 112125305 113015456 113025965 113036376 113047028 113057498 113078339 113078575 113099294 113099575 131110079 131110411 131110588 140111243 140211676 140211878 140412472 140412889 140513351
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    0.B. PACK - - || (1) TABLE COVER 44" x 90" || (1) UNDERBUTTOCK DRAPE WITH POUCH || (2) LEGGINS WITH 7" CUFF 30" x 42" || (1) GOWN IMPERVIOUS REINFORCED LARGE SMS || (3) TOWELS ABSORBENT 15" x 20" || (1) PAD OBSTETRICAL X-LARGE || (1) VAGINAL SPONGE XRD || (10) GAUZE SPONGES 4" X 4" 12PLY XRD || (1) CORD UMBILICAL CLAMP || (1) BABY BLANKET PRINTED || (2) EAR/ULCER SYRINGE 2oz || (1) SET UP COVER CLEAR POLY || (1) BASIN WASH 7QT. || (1) ABDOMINAL DRAPE WITH TAPE LIF || (2) KELLY FORCEP STRAIGHT 5 % || (1) MAYO SCISSOR STRAIGHT 6% || (1) BABY BEANNIES || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Dirección del fabricante
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
    Customed Inc
  • Source
    USFDA