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-2347-2014
  • Fecha de inicio del evento
    2014-05-20
  • Fecha de publicación del evento
    2014-08-29
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Orthopedic tray - Product Code OJH
  • 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

  • Modelo / Serial
    Product code 900-741A, 2 lots: 140412701 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿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
    ORTHO IMPLANT SURGICAL PACK - || (1) CAUTERY TIP POLISHER || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" || (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" || (1) TUBE SUCTION CONNECT. }4" X 12' || (1) DURAPREP SURGICAL SOLUTION 26ml || (1) BAG GLASSINE || (1) YANKAUER SUCTION TUBE WITHOUT VENT || (2) LITE GLOVE || (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS || (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE || (1) STOCKINETTE IMPERVIOUS 14" X 48" || (1) MAYO STAND COVER REINFORCED || (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" || (5) ABSORBENT TOWELS 15" X 20" || (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV || (4) DRAPE UTILITY || (1) CAUTERY PENCIL ROCKER SWITCH || (5) LAP SPONGES PREWASH XRD || (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE || (2) DRAPE SHEET 70" X 100" STD SMS || (1) TIME OUT BEACON NON WOVEN || (1) STAPLE SKIN WIDE 35 ST. || (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER || (1) MAYO TRAY LARGE || (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG || (1) TOP DRAPE W/ADHES. 100" X 53" SMS || (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP || (2) BANDAGE ELASTIC 6" X 5"yds || (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK || (1) UTILITY BOWL 16oz || (1) NEEDLE HYPODERMIC 18G X 1Y2 || (2) UTILITY BOWL 32oz || (2) BLADE SURGICAL# 10 STAINLESS STEEL || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer

Manufacturer

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