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Atrium Medical Corporation recalls FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Recalled June 12, 2024 · FDA recall Z-2005-2024 · Atrium Medical
Hazard
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. · FDA Class II
Units
53,308 units (US: 11, 236; OUS: 42,072)
Sold at
Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.
Description
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Product
FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →