FDAFDA · Alimentos y medicamentos·N.º oficial Z-1269-2013
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
Publicado el 15 de mayo de 2013 · Inicio del retiro: 28 de marzo 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
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baxter Healthcare Corp.
- Distribuidor
- Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
- Lote
- A) Product Code 2N3371: Lots R12H23076, R12H30097, R12I0707, R12I08059, R12I25046, R12I2607, R12J11052, R12J12068, R12J13058R12K17057, R12L10084, R13A12057
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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