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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2218-2024

Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX -PG7F65SX -PG7F90SX -PG8F45MPX -PG8F45S -PG8F45SX -PG8F65SX -PG8F90SX -X9PG700001 The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

Publicado el 3 de julio de 2024 · Inicio del retiro: 22 de mayo 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

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Merit Medical Systems, Inc.
Distribuidor
Worldwide - 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Brazil, Canada, Cayman Island, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Republic of Korea, Mexico, New Zealand, Peru, South Africa, and Uruguay.
Lote
Catalog Code/Lot Number/UDI-DI PG4F45S H2409286 00884450531709 H2511381 00884450531709 H2532402 00884450531709 H2542733 00884450531709 H2602038 00884450531709 H2613452 00884450531709 H2655892 00884450531709 H2668983 00884450531709 H2684566 00884450531709 H2800559 00884450531709 H2808568 00884450531709 H2817152 00884450531709 H2830841 00884450531709 H2839229 00884450531709 H2852688 00884450531709 PG4F90S H2418703 00884450531716 H2478781 00884450531716 H2532524 00884450531716 H2542736 00884450531716 H2642436 00884450531716 H2662245 00884450531716 H2668984 00884450531716 H2684572 00884450531716 H2757247 00884450531716 H2763317 00884450531716 H2876572 00884450531716 PG5F45MP H2409290 00884450531914 H2478782 00884450531914 H2542737 00884450531914 H2633727 00884450531914 H2655894 00884450531914 H2662249 00884450531914 H2684571 00884450531914 H2722066 00884450531914 H2757249 00884450531914 H2777503 00884450531914 H2785759 00884450531914 H2821571 00884450531914 H2830842 00884450531914 PG5F45R H2418694 00884450531921 H2474337 00884450531921 H2532525 00884450531921 H2569083 00884450531921 H2684579 00884450531921 H2722072 00884450531921 H2757250 00884450531921 H2785760 00884450531921 H2800565 H2918260 PG5F45S H2412933 00884450531730 H2418701 00884450531730 H2460087 00884450531730 H2510831 00884450531730 H2542738 00884450531730 H2589671 00884450531730 H2598840 00884450531730 H2633728 00884450531730 H2652758 00884450531730 H2655895 00884450531730 H2673477 00884450531730 H2684561 00884450531730 H2748336 00884450531730 H2757252 00884450531730 H2785761 00884450531730 H2813084 00884450531730 H2821574 00884450531730 H2830844 00884450531730 H2839234 00884450531730 H2852691 00884450531730 H2862025 00884450531730 H2877519 00884450531730 H2892964 PG5F45S018 H2748630 00884450770757 H2757274 00884450770757 H2800643 00884450770757 H2830864 00884450770757 H2843966 00884450770757 PG5F90MP H2426296 00884450531952 H2478800 00884450531952 H2532526 00884450531952 H2792291 00884450531952 H2800566 00884450531952 PG5F90S H2409297 00884450531945 H2504194 00884450531945 H2542744 00884450531945 H2569086 00884450531945 H2598841 00884450531945 H2626371 00884450531945 H2662254 00884450531945 H2668986 00884450531945 H2684573 00884450531945 H2722078 00884450531945 H2757253 00884450531945 H2763268 00884450531945 H2777539 00884450531945 H2785763 00884450531945 H2800567 00884450531945 H2800568 00884450531945 H2839241 00884450531945 H2872518 00884450531945 H2887808 00884450531945 H2897442 00884450531945 PG5F90S018 H2748631 00884450770764 H2757275 00884450770764 PG6F45HS H2409312 00884450557501 H2511383 00884450557501 H2516396 00884450557501 H2542789 00884450557501 H2722076 00884450557501 H2830863 00884450557501 H2862773 00884450557501 PG6F45MP H2409315 00884450532065 H2460158 00884450532065 H2542749 00884450532065 H2589642 00884450532065 H2613479 00884450532065 H2613485 00884450532065 H2648624 00884450532065 H2652755 00884450532065 H2662277 00884450532065 H2673493 00884450532065 H2785774 00884450532065 H2830852 00884450532065 H2839244 00884450532065 H2849299 00884450532065 H2897440 00884450532065 PG6F45R H2409322 00884450532133 H2460159 00884450532133 H2474360 00884450532133 H2542752 00884450532133 H2626382 00884450532133 H2648626 00884450532133 H2662278 00884450532133 H2748573 00884450532133 H2777544 00884450532133 H2785776 00884450532133 H2800575 00884450532133 H2830853 00884450532133 H2843960 00884450532133 H2862729 00884450532133 H2872520 00884450532133 H2887812 00884450532133 H2908171 H2918266 PG6F45S H2405182 00884450531969 H2418685 00884450531969 H2425355 00884450531969 H2460116 00884450531969 H2510837 00884450531969 H2532527 00884450531969 H2542746 00884450531969 H2552118 00884450531969 H2552119 00884450531969 H2562918 00884450531969 H2562919 00884450531969 H2563291 00884450531969 H2563292 00884450531969 H2589672 00884450531969 H2598849 00884450531969 H2598851 00884450531969 H2613453 00884450531969 H2613454 00884450531969 H2613455 00884450531969 H2613
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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