FDAFDA · Alimentos y medicamentos·N.º oficial Z-1969-2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
Publicado el 20 de mayo de 2020 · Inicio del retiro: 9 de abril de 2020
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
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- BD SWITZERLAND SARL
- Distribuidor
- Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
- Lote
- Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Switzerland
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