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-2320-2014
  • 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=129158
  • 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
    Cesarean section kit - Product Code OHM
  • 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 900-403, 30 lots: 112020525 112030955 112031372 112051682 112062486 112093590 112104107 112125170 112125315 113015449 113015695 113025960 113036485 113046957 113057479 113057817 113068169 113078573 113088813 113099289 113099571 131110076 131110409 131110586 131210970 140211667 140311937 140312382 140412836 140513246
  • 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
    CESAREAN PACK - - || (7) TOWELS ABSORBENT 15" X 20" || (2) SCALPEL WEIGHTED SAFETY #1 0 || (1) BLANKET BABY 30" X 30" POLY ABS IMP || (1) BOWL UTILITY QUART 32oz. || (1) TUBE FEEDING 8Fr. 15" LONG || (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR || (1) BEANNIES BABY || (2) PAD OBSTRETICAL XLGE ST. || (1) SYRINGE 20cc W/0 NEEDLE LIL || (1) SYRINGE EAR/ULCER 2oz. || (1) BLANKET RECEIVING 100% COTION || (1) CLAMP UMBILICAL CORD ST. || (1) COVER TABLE REINFORCED 50" X 90" || (1) SYRINGE 10CC W/0 NEEDLE L/LOCK || (1) BOWL PLASTIC W/LID 80oz || (2) GOWN XL SMS IMPERVIOUS REINFORCED || (1) SHEET DRAPE 41" X 58" SMS || (1) DRAPE C SECTION W/POUCH 102" X 121" X 78" || (1) YANKAUER SUCTION TUBE W/0 VENT || (1) WRAPPER 30" X 30" || (15) SPONGE LAP PREWASH 18" X 18" XRD || (1) TIME OUT BEACON NON WOVEN ST. || (1) TUBE SUCTION CO NN ECT~" X 12' || (2) LIGHT SHIELD || (1) GOWN SURG REINF LARGE T/WRAP || (2) PK. STRIP STERI CLOSURE W' X 4" || (1) POLISHER CAUTERY TIP || (1) DRESSING COMP OP 4" X 14" || (1) COVER MAYO STAND REINFORCED || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER || 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