FDAFDA · Alimentos y medicamentos·N.º oficial Z-0440-2013
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
Publicado el 5 de diciembre de 2012 · Inicio del retiro: 31 de octubre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cooper Surgical, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.
- Lote
- Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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