Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.
Publicado el 24 de octubre de 2012 · Inicio del retiro: 2 de octubre de 2009
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
Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (See location of supports as # 7 and # 8 on backplate attachment). The backplates were manufactured as described in manufacturing instructions a
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Terumo Cardiovascular Systems Corporation
- Distribuidor
- Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.
- Lote
- No lot/serial number; Catalog number: PN 816280
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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