FDAFDA · Alimentos y medicamentos·N.º oficial Z-1097-2019
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
Publicado el 24 de abril de 2019 · Inicio del retiro: 21 de febrero de 2019
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
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- ICU Medical, Inc.
- Distribuidor
- Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
- Lote
- (a) REF CL-80S-4, Lot Numbers: 3820520, 3820521, 3844785 (b) REF CL-80S-5, Lot Numbers: 3820516, 3820523, 3839238, 3839239, 3844781, 3844782, 3853998, 3853999, 3866769, 3866770, 3872090, 3910645, 3932908, 3932910, 3946770, 3951236
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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