Z-1905-2024 Class II Ongoing
Recalled by Stryker Neurovascular
— Fremont, CA
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2024
- Initiation Date
- April 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 204
Product Description
Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2-PACK - CE, Catalog: 91416 TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914170 TREVO NXT 6X37+TRAK21+CAT6 3-PACK - CE, Catalog: SFP914190
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Catalog/UDI-DI/Lot: 90312/07613327299922/118881; 91412/07613327500684/48483279, 48483281, 48483294, 48696618, 48696619, 48696620, 48715713, 48834692, 48834695, 48834696; 91413/07613327500691/48483280, 48483284, 48483289, 48483291, 48483316, 48483317, 48696613, 48696622, 48696623, 48715711, 48715715; 91414/07613327500707/48447776, 48447778, 48447779, 48483290, 48483292, 48483293, 48483315, 48483318, 48483320, 48696624, 48715714, 48834690, 48834691, 48834694, 48834697, 48852726, 48852730, 48852731, 48852732, 48852734, 48852735, 48852737, 48852738; 91415/07613327500714/48483277, 48483283, 48483295, 48483296, 48483311, 48483312, 48696621, 48715712, 48715716, 48834688, 48834693, 48834698; 91416/07613327507904/47328863, 47328865, 47351815, 47351816, 47374814, 48500988, 48501006, 48501007, 48501008, 48501009, 48501010, 48501011, 48501012, 48501013, 48501014, 48540277, 48556780, 48556783, 48558375, 48588482, 48589876, 48641524, 50065509, 50065520, 50193572, 50260581, 50327385, 50327403, 50375186, 50375187, 50422577, 50422588, 50448274, 50738892, 50762691, 50762721, 50762722, 50786687, 50797491, 50797494, 50797495, 50886508, 51320490, 51320491, 51379394, 51379399, 51379400, 51379401, 51379402, 51379403, 51379404, 51379405, 51379406, 51379408, 51467927, 51489221, 51489230, 51489233, 51489234; SFP914170/07613327508055/48834689; SFP914190/07613327508079/48945914