Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.
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
- GoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092 GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343 GoPump Kit 510643, Lot 12-100332 - Lot 13-100183
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.