FDAFDA · Alimentos y medicamentos·N.º oficial Z-2561-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Publicado el 21 de agosto de 2024 · Inicio del retiro: 11 de junio 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
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Merit Medical Systems, Inc.
- Distribuidor
- U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Lote
- Catalog Number: K04-00791A UDI-DI code: 00884450148471 Lot Numbers: H2387533 H2408714 H2423858 H2447173 H2484854 H2509065 H2547204 H2557351 H2640509 H2669424 H2704230 H2770492 H2780739 H2792326 H2864128 H2869756 H2916432
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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