FDAFDA · Alimentos y medicamentos·N.º oficial Z-0430-2026
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
Publicado el 26 de noviembre de 2025 · Inicio del retiro: 17 de octubre de 2025
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
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- CareFusion 303, Inc.
- Distribuidor
- Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.
- Lote
- All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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