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-2354-2014
  • 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=129248
  • 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 900-851, 19 lots: 112093954 112114401 112125118 113015517 113046987 113047162 113057510 113067939 113078349 113088895 113099457 113109877 131110317 140111098 140211857 140312187 140412474 140513147 140513483
  • 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- || (1) BEANNIES BABY LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) COVER MAYO STAND REINFORCED LIF || (3) SHEET DRAPE 41 " X 58" SMS LIF || (5) TOWEL ABSORBENT 15" X 20" LIF || (15) SPONGE LAP PREWASH 18" X 18" XRD LIF || (1) YANKAUER SUCTION TUBE W/0 VENT L/F || (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF || (2) PAD OBSTETRICAL X-LARGE LIF || (1) SYRINGE EAR/ULCER 2oz. L/F || (1) BLANKET BABY PRINTED || (1) TUBE SUCTION CONNECT Y-1" X 12' LIF || (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF || (1) BLANKET RECEIVING 100% COTTON || (1) BOWL W/LID PLASTIC 80oz. || (1) UMBILICAL CORD CLAMP || (1) TUBE FEEDING PVC 8FR 15" LONG || (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF || (1) BAG SUTURE FLORAL || (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE || (1) SCALPEL W/HANDLE #1 0 || (1) SCALPEL W/HANDLE #20 || (2) BOWL UTILITY 16oz. LIF || (1) PVP PAINT 8" STICK SPONGE LIF || (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF || (1) PENCIL CAUTERY HAND SWITCHING LIF || (1) SCISSOR UMBILICAL 4.5" STRAIGHT || (1) WRAPPER 24" X 24" LIF || (1) PVP SCRUB 8" STICK SPONGE LIF || (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF || (1) TIME OUT BEACON NON WOVEN LIF || 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