FDAFDA · Alimentos y medicamentos·N.º oficial Z-2570-2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.
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 code/Lot Numbers: RTT14038MB/A 00884450680100 T2882458 T2775532 T2692992 T2745797 T2823440 T2758669 T2882467 T2855297 T2692990 T2864420 T2762237 T2701080 T2748465 T2872143 T2853478 T2865442 T2560919 T2607047 T2617261 T2933737 T2657108 T2886240
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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