FDAFDA · Alimentos y medicamentos·N.º oficial Z-0650-2013
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Publicado el 16 de enero de 2013 · Inicio del retiro: 2 de noviembre 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
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- California Medical Laboratories Inc
- Distribuidor
- Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
- Lote
- Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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