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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1055-2015

BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-slit septums covering injection sites, as well as vials designed for penetration with needless IV access cannula. 2) The blunt steel canula will be targeted for exiting applications of pointer cannula, where blunt steel cannula would provide increased safety. Such existing applications include: -Accessing pre-slit/pre-pierced IV septum ports -Providing for fluid transfer -Can be used as tubing adapter 3) The BD single use Hypodermic Syringe is intended for use by healthcare professional for general purpose fluid aspiration/injection.

Publicado el 11 de febrero de 2015 · Inicio del retiro: 19 de diciembre 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

The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Becton Dickinson & Company
Distribuidor
US Nationwide Distribution
Lote
Catalog #303348, Lot #4209518 Catalog #305064, Lot #4205576 Catalog #309644 Lot #4209524
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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