Device Recall The Cure Pediatric Catheter 10Fr

  • Modelo / Serial
    Lot Number: 140417-3
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Pediatric, 10Fr, Intermittent Urinary Catheters || Model: P10 || Pouch Label UPC (P10) *+M405P100C* || Intermediate Box Label UPC (P10) *+M405P103F* || Carton Label UPC (P10) *+M405P105H* || The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). || There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. || Intended to be used by pediatric males and females for the purpose of bladder drainage
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cure Medical LLC, 3700 Newport Blvd Ste 301, Newport Beach CA 92663-3946
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA