Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
Publicado el 12 de junio de 2013 · Inicio del retiro: 10 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
Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Symbios Medical Products, LLC
- Distribuidor
- US Nationwide distribution.
- Lote
- Pump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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