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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1454-2013

Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 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. The medication is delivered via tubing to the surgical site at a very slow rate

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 510180, Lot 11-100453 to 12-101003 found in: Go Pump Kit 510201-BP. Lot 12-100108 to 12-101538 Go Pump Kit 510349-BP. Lot 12-100935 Go Pump Kit 510642, Lot 12-100616 to 13-100590
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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