FDAFDA · Alimentos y medicamentos·N.º oficial Z-2557-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
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 / UDI-DI / Lot Numbers: BRC-BAL-INT-SL/B 00884450363102 T2581281 BRC-BAL-INT-SL/B 00884450363102 T2594451 BRC-BAL-INT-SL/B 00884450363102 T2606225 BRC-BAL-INT-SL/B 00884450363102 T2609782 BRC-BAL-INT-SL/B 00884450363102 T2628321 BRC-BAL-INT-SL/B 00884450363102 T2643945 BRC-BAL-INT-SL/B 00884450363102 T2685079 BRC-BAL-INT-SL/B 00884450363102 T2712303 BRC-BAL-INT-SL/B 00884450363102 T2745782 BRC-BAL-INT-SL/B 00884450363102 T2758208 BRC-BAL-INT-SL/B 00884450363102 T2800973 BRC-BAL-INT-SL/B 00884450363102 T2805964 BRC-BAL-INT-SL/B 00884450363102 T2846532 BRC-BAL-INT-SL/B 00884450363102 T2846539 BRC-BAL-INT-SL/B 00884450363102 T2850757 BRC-BAL-INT-SL/B 00884450363102 T2901641
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.