FDAFDA · Alimentos y medicamentos·N.º oficial Z-0372-2014
*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.
Publicado el 27 de noviembre de 2013 · Inicio del retiro: 28 de agosto 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
Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hospira Inc.
- Distribuidor
- US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
- Lote
- *** 1) SYMBIQ One-Channel Infuser, List Number: 16026-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94; *** 2) SYMBIQ Two- Channel Infuser, List Number: 16027-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/ 93/94; *** X) Battery Pack E10 Part Number: HSP3566-E10; *** X) Battery Pack E09 Part Number: HSP3566-E09
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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