BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Publicado el 15 de octubre de 2014 · Inicio del retiro: 25 de agosto de 2014
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
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Navilyst Medical, Inc
- Distribuidor
- Nationwide Distribution
- Lote
- Batch/Lot Nos. 4745699 (exp. 31-Jan-16) and 4760237 (31-Jan-16)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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