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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1902-2024

Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK, Catalog: 80052 TREVO XP 4X30+PRO18 2-PACK, Catalog: 93067 TREVO XP 6X25+XT27 2-PACK, Catalog: 93068 TREVO XP 3X20+PRO14+CAT6 3-PACK - CE, Catalog: M0033PK32021002 TREVO XP 4X20+PRO18+CAT6 3-PACK - CE, Catalog: M0033PK42022002 TREVO XP 6X25+XT27+CAT6 3-PACK - CE, Catalog: M0033PK62523002

Publicado el 5 de junio de 2024 · Inicio del retiro: 23 de abril 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

Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Stryker Neurovascular
Distribuidor
Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
Lote
Catalog/UDI-DI/Lot: 90182/00815742001822/116706; 90183/00815742001839/117514; 90185/00815742001853/118900; 90186/00815742001860/114054; 80051/00815742000511/47307561, 47328877, 47351811, 47398058, 47398074, 48521577, 48521585, 48540280, 48540281, 48540282, 48540283, 48540284, 48556786, 48588490, 48607589, 48676218, 48696629, 48715720, 48736116, 48736122, 48754915, 48754920, 48772012, 48772014, 48772025, 50065499, 50065511, 50065512, 50065513, 50065514, 50065515, 50065518, 50113384, 50113385, 50133176, 50133191, 50193582, 50216273, 50216274, 50216277, 50239676, 50260575, 50260583, 50280979, 50281011, 50304688, 50304712, 50304713, 50304714, 50397877, 50422572, 50422582, 50422589, 50448279, 50519274, 50519275, 50519276, 50519277, 50519285, 50519295, 50577572, 50607374, 50607376, 50607377, 50607378, 50650278, 50650279, 50650288, 50673881, 50673884, 50673908, 50673909, 50673910, 50673911, 50673930, 50694279, 50738912, 50786710, 50850697, 50869887, 50869892, 50869905, 50886487, 50912493, 50912514, 50912515, 50912516, 50912517, 50931490, 50931518, 50931519, 50950402, 50967093, 51320497, 51350503, 51350505, 51489228, 51489235, 51513311, 51513516, 51535421, 51729133; 80052/00815742000528/49021114, 49021115, 49021116, 49021117, 49021118, 49033114, 49033115, 49033116, 49033117, 49052517, 49052525, 49192125, 49192140, 49192141, 49216723, 49216724, 49216737, 53175402; 93067/00815742000672/53320201; 93068/00815742000689/48963313, 49056315, 49155966, 49216725, 49318831, 49318836, 49318837, 49418740, 49418743, 49441346, 50000932, 50000933, 50000934, 50029333, 50029340, 50029361, 50047054, 50065482, 50065485, 50065486, 50065487; M0033PK32021002/07613327126334/48500990, 48624226, 48641523, 48641533, 50156372, 50519272, 50650290, 50912513, 50967091; M0033PK42022002/07613327126358/48995917, 49033123, 49140624, 49236926; M0033PK62523002/07613327126365/49033118, 49236935, 50047053
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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