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-2324-2014
  • 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=129162
  • 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 900-419, 16 lots: 112041449 112093941 112114601 113025847 113026169 113036364 113047313 113067871 113078327 113089073 113099292 131110077 131210815 140111228 140211670 140311939
  • 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
    LABOR & DELIVERY PAC - || 1) NEEDLE HYPODERMIC 18G X 1% ST. || (2) DRAPE UNDERBUTTOCK WITH POUCH || (4) TOWELS ABSORBENT 15" X 20" || ( 1) FEEDING TUBE 8FR, 15" LONG || ( 1) BEANNIES BABY || ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK || ( 1) UMBILICAL CORD CLAMP ST. || ( 1) RECEIVING BLANKET 100% COTTON || ( 1) TOWELS CLOTH HUCK (BLUE) || (2) LEGGINGS W/7" CUFF 30" X 42" || ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. || ( 1) BOWL PLASTIC 80oz || ( 1) LID FOR BOWL 80oz CLEAR || (20) GAUZE SPONGE 4" X 4" 16PLY || (2) PAD OBSTETRICAL X-LARGE ST. || ( 1) PACKING VAGINAL XRD 4 X 36 8PLY || ( 1) TABLE COVER REINFORCED 50" X 90" || ( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54" || (1 ) NEEDLE HYPODERMIC 21G X 1% ST. || (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK || (2) PVP SCRUB 8" STICK SPONGES ST. || ( 1) EAR ULCER SYRINGE 2oz. || ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED || (2) WRAPPER 30" X 30" || ( 1) PVP PAINT 8" STICK SPONGE ST. || (2) GLOVE SURG DERMA PRENE #7 % PF || (1) TIME OUT BEACON NON WOVEN ST. || (1) VACUTAINER GREEN NAHEP 10ML || 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