AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Publicado el 19 de junio de 2013 · Inicio del retiro: 24 de mayo de 2013
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
Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Fenwal Inc
- Distribuidor
- USA Nationwide Distribution
- Lote
- Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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