FDAFDA · Alimentos y medicamentos·N.º oficial Z-3302-2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888266130, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888266148, Sterile.
Publicado el 2 de octubre de 2024 · Inicio del retiro: 24 de julio de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardinal Health 200, LLC
- Distribuidor
- Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.
- Lote
- All lot numbers. UDI-DI numbers: (a) 8888266114, UDI-DI 10192253012781; (b) 8888266122, UDI-DI 10192253012804; (c) 8888266130, UDI-DI 10192253012828; and (d) 8888266148, UDI-DI 10192253012842.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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