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-2517-2014
  • 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=129557
  • 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 (kit) - Product Code LRO
  • 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
    Code 900-3025, 1 lot: 131110114
  • Clasificación del producto
    General and Plastic Surgery 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
    Chole Cystectomy All Endo System , code 900-3025, contains: || (1) TABLE COVER 44X 90 UF || (1) SYRINGE 20ccW/O NDL LUER LOCK LIF || (2) MAYO STAND COVER REINFORCED UF || (1) NEEDLE HYPODERMIC || (6) ABSORBENT TOWEL 15 X 20 UF || (1) NEEDLE HYPODERMIC 22G X 1Y. UF || (4) UTILITY DRAPE WIT APE UF || (1) TROCAR DILATING XCELL 5MM X 100 || (3) GOWN XL SURGICAL MICROCOOL L/F || (1) TROCAR ENDOPATH XCEL DILATING TIP || (1) WRAPPER 24" X 24" UF || (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF || (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF || (5) APPLICATOR COTTON 6 WOOD UF || (1) ULTRA VERES NEEDLE 120MM LIF || (1) APPLIER MUL Tl CLIP W/SHAF GUN || (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF || (2) DRAPE :Y. ECONOMY 53" X 77" UF || (2) UTLITY BOWL 16oz. UF || (1) SCALPEL WEIGHTED SAFETY #11 UF || (1) RING BASIN || (1) TIME OUT BEACON NON WOVEN UF || (1) TUBE SUCTION CONNECT || (1) MERLING SKIN PREP APPLIC 39ML UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF || (2) TOWEL CLOTH HUCK (BLUE) UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y UF || (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM || (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF || (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM || (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF || (2) LIGHT SHIELD UF || (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 || (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 || (1) PK. STERI STRIP CLOSURE || (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF || (1) MAYO TRAY SMALL || (1) SYRINGE 30ML SLIP TIP 1 ML UF || Product Usage: || 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