FDAFDA · Alimentos y medicamentos·N.º oficial Z-1608-2013
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.
Publicado el 3 de julio de 2013 · Inicio del retiro: 31 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
Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Greatbatch Medical
- Distribuidor
- Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and ITALY.
- Lote
- Manufacturing Lot : W18499722
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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