Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are n
Check against the official notice below — it lists the full affected range.
Medtronic Vascular issued a recall of angiographic guidewire components in model numbers 107042, 107044, 107447, 110003, and 110004. The components were intended to be shipped to a third-party manufacturer for further processing and sterilization but were instead shipped directly to customers. A total of 54,997 units were distributed across the United States (including California, Kentucky, Louisiana, Michigan, Nebraska, New York, Ohio, Oklahoma, Texas, Washington, and Wisconsin) and to Australia.
The recalled products are identified by specific lot numbers and GTINs listed in the record. According to the recall documentation, no remedy is specified for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
Reason for recall: The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers. Distribution: US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia Quantity: 54,997 units Lot/code info: GTIN: 00673978284569, 20613994885306, 00673978284576, 00673978284620, 20613994885337,00673978284729, 20613994885399, 20613994994534. Serial Number/Lot Number GFRF0544 GFTJ1064 GFTJ2054 GFWD3486 GFAP4022 GFAP4023 GFAR1705 GFAS0270 GFAS0271 GFAU2099 GFAU2100 GFAV2023 GFAW0536 GFAX0346 GFAX0347 GFAX0348 GFAX0349 GFAY0671 GFAY0672 GFAZ0120 GFAZ0121 GFBN0459 GFBP1047 GFBP1048 GFBQ1629 GFBQ1630 GFBQ1631 GFBW0577 GFCV1818 GFCX1086 GFDP0187 GFWE3973 GFWE3974 GFWF3611 GFWG4429 GFWG4430 GFWG4432 GFWH2553 GFWI3563 GFWK0060 GFWK0061 GFWK0062 GFWL0066 GFWL2778 GFWL2780 GFXB0138 GFXB0141 GFXB3088 GFXB3089 GFXB3090 GFXC3702 GFXC3703 GFXD4073 GFXD4074 GFXF2023 GFXF2024 GFXF2025 GFXG1318 GFXG1320 GFXH2124 GFXH2125 GFXI1282 GFXI1445 GFXJ0688 GFXJ0689 GFYE0603 GFYF0667 GFYG1165 GFZA1155 GFZA1156 GFZB0256 GFZB0257 GFZC1428 GFZF0937 GFZH0811 GFZH0812 GFZJ1128 GFUG2639 GFTH1503 GFTJ0708 GFBY3756 GFXJ0691 GFRI1386 GFXC3695 GFXI1280 GFYA2177 GFYK1425 GFYK1426 GFYL2107 GFZA1161 GFZA1162 GFZB1164 GFZB1165 GFZB1166 GFZC0833 GFZC0834 GFZC0835 GFAN0034 GFAN3402 GFAQ4326 GFAS1779 GFAT2205 GFAU2102 GFAV2025 GFAW0540 GFAX0351 GFAY2480 GFAZ1728 GFBN0463 GFBP1051 GFBP2548 GFBQ2337 GFBS2989 GFBT1262 GFBU1912 GFBU1913 GFBV2111 GFBW0580 GFBX2576 GFBX2578 GFBY0801 GFCT1918 GFCU1707 GFCV3653 GFCW0885 GFCX3692 GFCY3186 GFCZ1176 GFDP1294 GFDQ1045 GFDR0722 GFDT3017 GFDT3533 GFDV0352 GFDV3567 GFDV3568 GFDW2107 GFDW2108 GFDX2649 GFDY2057 GFER1570 GFEV0322 GFEV0323 GFEV0325 GFYG1612 GFYI0525 GFYI0722 GFYJ0508 GFYJ2628 G
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.