FDAFDA · Alimentos y medicamentos·N.º oficial Z-1967-2016
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Publicado el 22 de junio de 2016 · Inicio del retiro: 14 de marzo de 2016
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
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Navilyst Medical, Inc., an AngioDyamics Company
- Distribuidor
- Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
- Lote
- Batch/Lots:1) 4714745 with Use By 2016-03-31. Batch/Lots: 2) 4745413, 4819467, 4827954, 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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