Events

Rappel de Device Recall Triton Infusion Pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par WalkMed Infusion, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74436
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2219-2016
  • Date de mise en oeuvre de l'événement
    2016-06-14
  • Date de publication de l'événement
    2016-07-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147528
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    Walkmed infusion, llc announces a voluntary field action of the triton infusion pump (model 300000) and triton fp infusion pump (model 400000) due to unapproved changes to the software and specifications of the triton infusion pump (model 300000) and unapproved changes to the intended use of the triton fp infusion pump (model 400000).
  • Action
    WalkMed sent an Urgent : Medical Device Recall letter dated June 14, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by Users: WalkMed recommends the following actions be taken with respect to the recalled product: Our records indicate that you have received Triton pumps. Immediately review your inventory and determine whether you have any of the Triton or Triton fp infusion pumps (model numbers 300000 and 400000). Please complete and promptly return the enclosed recall response form, even if you do not have any affected stock subject to this recall notice. WalkMed recommends that users stop use of and replace the Triton and Triton fp Infusion pumps with alternative devices as soon as possible. To ensure that patients who use WalkMed Triton infusion pumps can continue to receive infusion therapies without interruption, WalkMed will support customers in their transition to alternative devices. To ensure continuity of patient care, WalkMed will continue to provide IV administration sets to existing customers, provide preventive maintenance and service for distributed pumps and make available any parts necessary for the repair or service of units for up to 3 months from the date of this recall notice. Contact WalkMed at (303) 420-9569 to arrange for shipment of the product being returned. If an owner of a Triton or Triton fp infusion pump is interested in information about options for a replacement product, please contact WalkMed. For further questions please call (303) 420-9569.

Device

Device Recall Triton Infusion Pump
  • Modèle / numéro de série
    TR1041, TR1043, TR1044, TR1047, TR1049, TR1051, TR1053, TR1054, TR1055, TR1056, TR1058, TR1059, TR1060, TR1061, TR1062, TR1063, TR1064, TR1065, TR1066, TR1067, TR1068, TR1069, TR1070, TR1071, TR1072, TR1073, TR1074, TR1077, TR1078, TR1079, TR1080, TR1081, TR1082, TR1083, TR1084, TR1085, TR1086, TR1087, TR1088, TR1089, TR1090, TR1091, TR1093, TR1094, TR1095, TR1096, TR1097, TR1099, TR1100, TR1101, TR1102, TR1105, TR1106, TR1107, TR1109, TR1110, TR1111, TR1113, TR1114, TR1115, TR1116, TR1117, TR1118, TR1120, TR1121, TR1122, TR1123, TR1124, TR1125, TR1126, TR1127, TR1128, TR1129R, TR1131, TR1132, TR1133, TR1134, TR1136, TR1137, TR1138, TR1141, TR1142, TR1143, TR1144, TR1145, TR1146, TR1147, TR1148, TR1149, TR1150, TR1151, TR1154, TR1156, TR1157, TR1158, TR1159, TR1160, TR1161, TR1163, TR1164, TR1165, TR1166, TR1167, TR1168, TR1169, TR1170, TR1171, TR1172, TR1173, TR1174, TR1175, TR1176, TR1177, TR1178, TR1179, TR1180, TR1182, TR1183, TR1184, TR1185, TR1186, TR1187, TR1190, TR1191, TR1192, TR1193, TR1194, TR1195, TR1197, TR1198, TR1200, TR1201, TR1202, TR1203, TR1204, TR1205, TR1206, TR1207, TR1208, TR1209, TR1210, TR1211, TR1212, TR1213, TR1216, TR1218, TR1219, TR1220, TR1222, TR1223, TR1224, TR1226, TR1227, TR1228, TR1229, TR1230, TR1234, TR1235, TR1236, TR1238, TR1239, TR1240, TR1241, TR1243, TR1246, TR1247, TR1248, TR1249, TR1250, TR1251, TR1252, TR1252R, TR1253, TR1254, TR1255, TR1256, TR1257, TR1258, TR1261, TR1263, TR1264, TR1266, TR1269, TR1270, TR1271, TR1272, TR1273, TR1274, TR1275, TR1276, TR1277, TR1278, TR1279, TR1280, TR1281, TR1282, TR1283, TR1284, TR1285, TR1286, TR1287, TR1288, TR1289, TR1290, TR1291, TR1292, TR1293, TR1294, TR1295, TR1296, TR1297, TR1298, TR1299, TR1300, TR1301, TR1302, TR1303, TR1304, TR1305, TR1306, TR1307, TR1308, TR1309, TR1310, TR1311, TR1312, TR1313, TR1314, TR1315, TR1317, TR1318, TR1319, TR1320, TR1321R, TR1322, TR1323, TR1324, TR1325, TR1326, TR1327, TR1328, TR1329, TR1330, TR1332, TR1335, TR1336, TR1339, TR1341, TR1342, TR1344R, TR1346, TR1347, TR1348, TR1349, TR1351, TR1352, TR1353, TR1354, TR1355, TR1356, TR1358, TR1359, TR1360, TR1361, TR1363, TR1364, TR1365, TR1366, TR1367, TR1368, TR1370, TR1371, TR1372, TR1373, TR1375, TR1377, TR1378, TR1379, TR1380, TR1381, TR1383, R1384R, TR1385, TR1387, TR1388, TR1389, TR1390, TR1391, TR1392, TR1393, TR1394, TR1395, TR1396, TR1399, TR1400, TR1401, TR1403, TR1407, TR1409, TR1411, TR1412, TR1413, TR1414, TR1415, TR1417, TR1418, TR1419, TR1420, TR1421, TR1422, TR1423, TR1424, TR1425, TR1426, TR1427, TR1428, TR1429, TR1430, TR1432, TR1433, TR1436, TR1437, TR1439, TR1440, TR1443, TR1444, TR1445, TR1446, TR1447, TR1449, TR1450, TR1451, TR1452, TR1453, TR1454, TR1455, TR1456, TR1457, TR1458, TR1459, TR1462, TR1463, TR1465, TR1466, TR1467, TR1468, TR1470, TR1471, TR1472, TR1474, TR1475, TR1476, TR1477, TR1478, TR1480, TR1481, TR1482, TR1483, TR1486, TR1487, TR1488, TR1489, TR1490, TR1491, TR1493, TR1496, TR1497, TR1498, TR1499, TR1500, TR1502, TR1504, TR1505, TR1506, TR1508, TR1509, TR1510, TR1511, TR1512, TR1515, TR1516, TR1520, TR1521, TR1522, TR1524, TR1527, TR1529, TR1531, TR1532, TR1535, TR1536, TR1537, TR1538, R1539R, R1540R, TR1545, TR1546, TR1547, TR1548, TR1549, TR1550, TR1551, TR1554, TR1555, TR1556, TR1558, TR1559, TR1560, TR1562, TR1563, TR1564, TR1566, TR1567, TR1568, TR1571, TR1572, TR1573, TR1574, TR1575, TR1576, TR1577, TR1579, TR1580, TR1581, TR1582, TR1584, TR1587, TR1588, TR1589, TR1590, TR1592, TR1593, TR1594, TR1595, TR1597, TR1598, TR1599, TR1600, TR1601, TR1602, TR1603, TR1606, TR1607, TR1608, TR1612, TR1613, TR1614, TR1617, TR1618, TR1620, TR1622, TR1625, TR1627, TR1630, TR1631, TR1634, TR1635, TR1636, TR1637, TR1640, TR1642, TR1643, TR1645, TR1646, TR1647, TR1650, TR1651, TR1653, TR1654, TR1656, TR1657, TR1660, TR1661, TR1663, TR1664, TR1665, TR1666, TR1668, TR1670, TR1671, TR1672, TR1673, TR1674, TR1677, TR1679, TR1680, TR1681, TR1682, TR1683, TR1684, TR1685, TR1687, TR1689, TR1691, TR1692, TR1694, TR1695, TR1697, TR1698, TR1699, TR1700, TR1701, TR1703, TR1704, TR1705, TR1706, TR1707, TR1708, TR1710, TR1711, TR1712, TR1713, TR1715, TR1716, TR1718, TR1720, TR1721, TR1724, TR1725, TR1726, TR1727, TR1729, TR1730, TR1731, TR1732, TR1733, TR1734, TR1735, TR1739, TR1740, TR1741, TR1742, TR1743, TR1744, TR1745, TR1746, TR1748, TR1749, TR1750, TR1751, TR1752, TR1753, TR1754, TR1755, TR1756, TR1757, TR1758, TR1759, TR1760, TR1762, TR1763, TR1765, TR1766, TR1768, TR1769, TR1770, TR1771, TR1772, TR1773, TR1774, TR1775, TR1777, TR1778, TR1779, TR1781, TR1782, TR1784, TR1785, TR1787, TR1788, TR1789, TR1790, TR1791, TR1792, TR1793, TR1794, TR1795, TR1796, R1799R, TR1800, TR1801, TR1803, TR1804, TR1805, TR1806, TR1807, TR1808, TR1809, TR1811, TR1813, TR1814, TR1815, TR1816, TR1817, TR1820, TR1821, TR1822, TR1823, R1824R, TR1825, TR1826, TR1827, TR1828, TR1829, TR1830, TR1832, TR1833, TR1834, TR1835, TR1836, TR1837, TR1838, TR1839, TR1841, TR1842, TR1843, TR1844, TR1845, TR1846, TR1847, TR1849, TR1850, TR1853, TR1854, TR1856, TR1858, TR1859, TR1860, TR1861, TR1862, TR1863, TR1864, TR1865, TR1866, TR1868, TR1871, TR1872, TR1873, R1874R, TR1875, TR1876, TR1877, TR1878, TR1879, TR1881, TR1882, TR1884, TR1885, TR1886, TR1887, TR1888, TR1889, TR1890, TR1891, TR1893, TR1899, TR1901, TR1902, TR1903, TR1904, TR1905, TR1908, TR1909, TR1910, TR1911, TR1912, TR1913, TR1914, TR1915, TR1916, TR1917, TR1920, TR1921, TR1924, TR1925, TR1926, TR1927, TR1928, TR1931, TR1932, TR1933, TR1934, TR1935, TR1936, TR1937, TR1938, TR1939, TR1941, TR1942, TR1943, TR1944, TR1945, TR1946, TR1947, TR1949, TR1950, TR1952, TR1954, TR1955, TR1956, TR1958, TR1959, TR1960, TR1961, TR1962, TR1964, TR1965, TR1966, TR1968, TR1969, TR1970, TR1971, TR1972, TR1973, TR1974, TR1975, TR1976, TR1977, TR1978, TR1979, TR1980, TR1981, TR1983, TR1984, TR1985, TR1986, TR1987, TR1988, TR1989, TR1991, TR1992, TR1993, TR1994, TR1995, TR1996, TR1997, TR1998, TR1999, TR2000, TR2001, TR2002, TR2003, TR2004, TR2006, TR2007, TR2008, TR2009, TR2010, TR2011, TR2012, TR2013, TR2014, TR2015, TR2016, TR2017, TR2018, TR2019, TR2020, TR2021, TR2022, TR2023, TR2024, TR2025, TR2026, TR2027, TR2029, TR2030, TR2032, TR2034, TR2037, TR2038, TR2040, TR2041, TR2042, TR2043, TR2044, TR2045, TR2047, TR2048, TR2049, TR2050, TR2051, TR2052, TR2053, TR2054, TR2055, TR2056, TR2057, TR2059, TR2060, TR2061, TR2062, TR2063, TR2064, TR2065, TR2066, TR2067, TR2068, TR2070, TR2071, TR2072, TR2074, TR2075, TR2076, TR2077, TR2078, TR2081, TR2082, TR2083, TR2084, TR2085, TR2087, TR2088, TR2089, TR2090, TR2091, TR2092, TR2093, TR2094, TR2095, TR2096, TR2097, TR2098, TR2099, TR2100, TR2101, TR2102, TR2103, TR2104, TR2106, TR2107, TR2108, TR2109, TR2110, TR2111, TR2112, TR2113, TR2114, TR2115, TR2117, TR2118, TR2120, TR2121, TR2122, TR2123, TR2124, TR2126, TR2127, TR2128, TR2129, TR2133, TR2135, TR2138, TR2139, TR2140, TR2141, TR2143, TR2145, TR2146, TR2147, TR2148, TR2149, TR2150, TR2151, TR2152, TR2153, TR2155, TR2157, TR2158, TR2160, TR2162, TR2163, TR2165, TR2166, TR2170, TR2171, TR2175, TR2176, TR2177, TR2179, TR2180, TR2181, TR2183, TR2184, TR2187, TR2188, TR2190, TR2194, TR2195, TR2196, TR2197, TR2198, TR2199, TR2200, TR2203, TR2205, TR2206, TR2208, TR2209, TR2210, TR2211, TR2212, TR2213, TR2214, TR2215, TR2216, TR2217, TR2219, TR2220, TR2221, TR2222, TR2224, TR2226, TR2227, TR2229, TR2230, TR2231, TR2232, TR2233, TR2235, TR2236, TR2238, TR2240, TR2241, TR2242, TR2243, TR2244, TR2245, TR2247, TR2249, TR2250, TR2251, TR2252, TR2254, TR2255, TR2256, TR2257, TR2258, TR2259, TR2260, TR2262, TR2263, TR2265, TR2266, TR2267, TR2268, TR2270, TR2271, TR2272, TR2273, TR2274, TR2276, TR2278, TR2279, TR2281, TR2282, TR2283, TR2284, TR2286, TR2287, TR2288R, TR2290, TR2291, TR2293, TR2294, TR2295, TR2296, TR2298, R2299R, TR2301, TR2302, TR2304, TR2305, TR2306, TR2307, TR2308, TR2309, TR2310, TR2311, TR2312, TR2313, TR2314, TR2315, TR2316, TR2317, TR2319, TR2320, TR2321, TR2322, TR2324, TR2325, TR2326, TR2327, TR2330, TR2331, TR2332, TR2334, TR2335, TR2336, TR2337, TR2338, TR2339, TR2340, TR2341, TR2342, TR2343, TR2345, TR2347, TR2348, TR2349, TR2350, TR2351, TR2352, TR2353, TR2354, TR2355, TR2356, TR2357, TR2358, TR2359, TR2364, TR2365, TR2366, TR2367, TR2368, TR2369, TR2371, TR2372, TR2373, TR2374, TR2375, TR2376, TR2377, TR2379, TR2382, TR2383, TR2384, TR2386, TR2388, TR2389, TR2390, TR2391, TR2392, TR2393, TR2395, TR2396, TR2397, TR2399, TR2401, TR2402, TR2403, TR2404, TR2405, TR2406, TR2407, TR2409, TR2410, TR2413, TR2414, TR2415, TR2417, TR2418R, TR2419, TR2423, TR2425, TR2426, TR2428, TR2431, TR2432, TR2435, TR2436, TR2437, TR2438, TR2439, TR2441, TR2442, TR2443, TR2444, TR2445, TR2446, TR2448, TR2451, TR2452, TR2453, TR2454, TR2455, TR2456, TR2457, TR2458, TR2460, TR2461, TR2463, TR2465, TR2468, TR2469, TR2470, TR2471, TR2472, TR2473, TR2474, TR2475, TR2476, TR2477, TR2478, TR2481, TR2483, TR2485, TR2487, TR2488, TR2489, TR2490, TR2491, TR2492, TR2493, TR2495, TR2497, TR2498, TR2499, TR2500, TR2501, TR2502, TR2503, TR2504, TR2505, TR2507, TR2508, TR2509, TR2510, TR2512, TR2513, TR2514, TR2515, TR2516, TR2517, TR2518, TR2519, TR2520, TR2521, TR2522, TR2523, TR2525, TR2526, TR2528, TR2529, TR2530, TR2531, TR2533, TR2535, TR2537, TR2538, TR2539, TR2540, TR2542, TR2543, TR2544, TR2545, TR2546, TR2547, TR2548, TR2549, TR2550, TR2551, TR2552, TR2553, TR2554, TR2555, TR2556, TR2557, TR2559, TR2560, TR2561, TR2562, TR2563, TR2564, TR2565, TR2566, TR2567, TR2568, TR2569, TR2570, TR2571, TR2572, TR2573, TR2574, TR2575, TR2576, TR2577, TR2578, TR2579, TR2580, TR2581, TR2583, TR2584, TR2585, TR2586, TR2587, TR2588, TR2589, TR2590, TR2591, TR2592, TR2593, TR2594, TR2595, TR2596, TR2597, TR2599, TR2600, TR2601, TR2603, TR2604, TR2605, TR2606, TR2607, TR2608, TR2610, TR2612, TR2613, TR2616, TR2618, TR2619, TR2620, TR2621, TR2622, TR2623, TR2624, TR2625, TR2626, TR2627, TR2628, TR2629, TR2631, TR2632, TR2633, TR2635, TR2636, TR2638, TR2639, TR2640, TR2641, TR2642, TR2643, TR2644, TR2645, TR2646, TR2648, TR2649, TR2650, TR2652, TR2654, TR2655, TR2656, TR2657, TR2658, TR2659, TR2660, TR2661, TR2662, TR2663, TR2664, TR2665, TR2667, TR2668, TR2669, TR2670, TR2671, TR2672, TR2673, TR2674, TR2675, TR2676, TR2677, TR2678, TR2679, TR2680, TR2681, TR2682, TR2683, TR2684, TR2685, TR2687, TR2688, TR2689, TR2690, TR2691, TR2692, TR2693, TR2694, TR2695, TR2696, TR2697, TR2698, TR2699, TR2700, TR2701, TR2702, TR2703, TR2704, TR2705, TR2706, TR2707, TR2708, TR2709, TR2710, TR2712, TR2713, TR2714, TR2715, TR2716, TR2717, TR2718, TR2719, TR2720, TR2721, TR2723, TR2724, TR2726, R2727R, TR2728, TR2729, TR2730, TR2731, TR2732, TR2733, TR2734, TR2735, TR2736, TR2738, TR2739, TR2740, TR2741, TR2742, TR2743, TR2744, TR2745, TR2746, TR2747, TR2748, TR2749, TR2750, TR2751, TR2752, TR2753, TR2754, TR2755, TR2756, TR2757, TR2758, TR2759, TR2761, TR2762, TR2763, TR2764, TR2766, TR2767, TR2768, TR2769, TR2770, TR2771, TR2772, TR2773, TR2774, TR2775, TR2776, TR2777, TR2778, TR2779, TR2780, TR2781, TR2782, TR2783, TR2784, TR2786, TR2787, TR2789, TR2790, TR2791, TR2792, TR2793, TR2794, TR2795, TR2796, TR2797, TR2798, TR2799, TR2800, TR2801, TR2802, TR2803, TR2804, TR2805, TR2806, TR2807, TR2808, TR2809, TR2810, TR2812, TR2813, TR2814, TR2815, TR2816, TR2817, TR2818, TR2819, TR2820, TR2821, TR2822, TR2823, TR2825, TR2826, TR2827, TR2828, TR2829, TR2830, TR2831, TR2832, TR2833, TR2834, TR2835, TR2836, TR2837, TR2840, TR2841, TR2843, TR2845, TR2846, TR2847, TR2848, TR2849, TR2850, TR2851, TR2852, TR2853, TR2854, TR2855, TR2856, TR2857, TR2858, TR2859, TR2860, TR2861, TR2862, TR2863, TR2864, TR2865, TR2866, TR2867, TR2868, TR2869, TR2870, TR2871, TR2872, TR2873, TR2874, TR2875, TR2876, TR2877, TR2878, TR2879, TR2880, TR2881, TR2882, TR2883, TR2884, TR2885, TR2886, TR2887, TR2888, TR2889, TR2890, TR2892, TR2893, TR2894, TR2895, TR2896, TR2897, TR2898, TR2899, TR2900, TR2902, TR2903, TR2904, TR2905, TR2906, TR2907, TR2908, TR2909, TR2910, TR2911, TR2912, TR2913, TR2914, TR2915, TR2916, TR2917, TR2918, TR2919, TR2920, TR2921, TR2922, TR2923, TR2924, TR2925, TR2927, TR2930, TR2933, TR2935, TR2938, TR2939, TR2940, TR2942, TR2943, TR2946, TR2952, TR2955, TR2986, TR2987, TR2988, TR2989, TR2990, TR2991, TR2992, TR2993, TR2995, TR2996, TR2997, TR2998, TR2999, TR3000, TR3001, TR3002, TR3003, TR3004, TR3005, TR3006, TR3007, TR3008, TR3009, TR3010, TR3011, TR3012, TR3014, TR3015, TR3016, TR3017, TR3018, TR3019, TR3020, TR3021, TR3022, TR3023, TR3024, TR3025, TR3026, TR3027, TR3029, TR3030, TR3031, TR3033, TR3034, TR3035, TR3040, TR3041, TR3043, TR3045, TR3046, TR3047R, TR3048, TR3049, TR3052, TR3054, TR3055, TR3056, TR3057, TR3058, TR3059, TR3060, TR3061, TR3063, TR3064, TR3065, TR3066, TR3067, TR3068, TR3069, TR3072, TR3073, TR3074, TR3075, TR3076, TR3078, TR3079, TR3080, TR3081, TR3082, TR3085, TR3086, TR3087, TR3088, TR3090, TR3091, TR3092, TR3093, TR3094, TR3095, TR3096, TR3097, TR3100, TR3102, TR3103, TR3104, TR3105, TR3106, TR3107, TR3108, TR3109, TR3110, TR3111, TR3112, TR3113, TR3114, TR3115, TR3116, TR3118, TR3119, TR3120, TR3121, TR3122, TR3123, TR3124, TR3125, TR3126, TR3127, TR3129, TR3132, TR3133, TR3134, TR3135, TR3136, TR3137, TR3138, TR3140, TR3141, TR3142, TR3143, TR3144, TR3147, TR3148, TR3149, TR3151, TR3152, TR3153, TR3154, TR3155, TR3156, TR3157, TR3159, TR3160, TR3161, TR3162, TR3163, TR3164, TR3165, TR3166, TR3167, TR3168, TR3169, TR3170, TR3171, TR3172, TR3173, TR3174, TR3175, TR3176, TR3177, TR3178, TR3179, TR3180, TR3181, TR3182, TR3183, TR3184, TR3185, TR3187, TR3188, TR3189, TR3190, TR3191, TR3192, TR3193, TR3194, TR3195, TR3196, TR3197, TR3198, TR3199, TR3200, TR3201, TR3202, TR3203, TR3204, TR3205, TR3206, TR3207, TR3208, TR3209, TR3210, TR3211, TR3213, TR3215, TR3216, TR3217, TR3218, TR3219, TR3220, TR3221, TR3222, TR3223, TR3224, TR3225, TR3226, TR3227, TR3228, TR3229, TR3230, TR3231, TR3232, TR3233, TR3234, TR3235, TR3236, TR3237, TR3238, TR3240, TR3242, TR3244, TR3245, TR3246, TR3247, TR3248, TR3249, TR3251, TR3252, TR3253, TR3254, TR3255, TR3256, TR3257, TR3258, TR3259, TR3260, TR3261, TR3262, TR3263, TR3264, TR3265, TR3266, TR3267R, TR3269, TR3270, TR3271, TR3272, TR3273, TR3274, TR3275, TR3277, TR3279, TR3280, TR3281, TR3282, TR3283, TR3285, TR3287, TR3288, TR3289, TR3290, TR3291, TR3292, TR3293, TR3294, TR3295, TR3296, TR3297, TR3299, TR3300, TR3301, TR3302, TR3303, TR3304, TR3305, TR3306, TR3307, TR3308, TR3309, TR3310, TR3311, TR3312, TR3313, TR3314, TR3315, TR3316, TR3317, TR3318, TR3319, TR3320R, TR3321, TR3322, TR3323, TR3324, TR3325, TR3326, TR3327, TR3328, TR3329, TR3330, TR3331, TR3332, TR3333, TR3334, TR3335, TR3336, TR3337, TR3338, TR3339, TR3340, TR3341, TR3342, TR3343, TR3344, TR3345, TR3346, TR3347, TR3348, TR3349, TR3350, TR3351, TR3352, TR3353, TR3354, TR3355, TR3356, TR3357, TR3358, TR3359, TR3360, TR3361, TR3362, TR3363, TR3364, TR3365, TR3366, TR3367, TR3368, TR3369, TR3370, TR3371, TR3372, TR3373, TR3374, TR3375, TR3376, TR3377, TR3378, TR3379, TR3380, TR3381, TR3382, TR3383, TR3384, TR3385, TR3386, TR3387, TR3388, TR3389, TR3390, TR3391, TR3392, TR3393, TR3395, TR3396, TR3397, TR3398, TR3399, TR3400, TR3401, TR3402, TR3403, TR3404, TR3405, TR3406, TR3407, TR3408, TR3409, TR3410, TR3412, TR3413, TR3414, TR3415, TR3416, TR3417, TR3418, TR3419, TR3420, TR3421, TR3422, TR3423, TR3424, TR3425, TR3426, TR3427, TR3428, TR3429, TR3430, TR3431, TR3432, TR3433, TR3434, TR3435, TR3436, TR3437, TR3438, TR3439, TR3440, TR3441, TR3442, TR3443, TR3444, TR3445, TR3446, TR3447, TR3448, TR3450, TR3451, TR3452, TR3453, TR3454, TR3455, TR3456, TR3457, TR3458, TR3459, TR3460, TR3461, TR3462, TR3463, TR3464, TR3465, TR3466, TR3467, TR3468, TR3469, TR3470, TR3471, TR3472, TR3473, TR3474, TR3475, TR3476, TR3477, TR3478, TR3479, TR3480, TR3481, TR3482, TR3483, TR3484, TR3486, TR3487, TR3488, TR3489, TR3490, TR3491, TR3492, TR3493, TR3494, TR3495, TR3496, TR3497, TR3498, TR3499, TR3500, TR3501, TR3502, TR3503, TR3504, TR3505, TR3506, TR3507, TR3508, TR3509, TR3510, TR3511, TR3512, TR3513, TR3514, TR3515, TR3516, TR3517, TR3518, TR3519, TR3520, TR3521, TR3522, TR3523, TR3524, TR3525, TR3526, TR3527, TR3528, TR3529, TR3530, TR3531, TR3532, TR3533, TR3534, TR3535, TR3536, TR3537, TR3538, TR3539, TR3540, TR3541, TR3542, TR3543, TR3544, TR3545, TR3546, TR3547, TR3548, TR3549, TR3550, TR3551, TR3552, TR3553, TR3554, TR3555, TR3556, TR3557, TR3558, TR3559, TR3560, TR3561, TR3562, TR3563, TR3564, TR3565, TR3566, TR3567, TR3568, TR3569, TR3570, TR3571, TR3572, TR3573, TR3574, TR3575, TR3576, TR3577, TR3578, TR3579, TR3580, TR3581, TR3582, TR3583, TR3584, TR3585, TR3586, TR3587, TR3588, TR3589, TR3590, TR3591, TR3592, TR3593, TR3594, TR3595, TR3596, TR3597, TR3598, TR3599, TR3600, TR3601, TR3602, TR3603, TR3604, TR3605, TR3606, TR3607, TR3608, TR3609, TR3610, TR3611, TR3612, TR3613, TR3614, TR3615, TR3616, TR3617, TR3618, TR3619, TR3620, TR3621, TR3622, TR3623, TR3624, TR3625, TR3626, TR3627, TR3628, TR3629, TR3630, TR3631, TR3632, TR3633, TR3634, TR3635, TR3636, TR3637, TR3638, TR3639, TR3640, TR3641, TR3642, TR3643, TR3644, TR3646, TR3647, TR3648, TR3649, TR3650, TR3651, TR3652, TR3653, TR3654, TR3655, TR3656, TR3657, TR3658, TR3659, TR3660, TR3661, TR3662, TR3663, TR3664, TR3665, TR3666, TR3667, TR3668, TR3669, TR3670, TR3671, TR3672, TR3673, TR3674, TR3675, TR3676, TR3677, TR3678, TR3679, TR3680, TR3681, TR3682, TR3683, TR3684, TR3685, TR3686, TR3687, TR3688, TR3689, TR3690, TR3691, TR3692, TR3693, TR3694, TR3695, TR3696, TR3697, TR3698, TR3699, TR3700, TR3701, TR3702, TR3703, TR3704, TR3705, TR3706, TR3707, TR3708, TR3709, TR3710, TR3711, TR3712, TR3713, TR3714, TR3715, TR3716, TR3717, TR3718, TR3719, TR3720, TR3721, TR3722, TR3723, TR3724, TR3725, TR3726, TR3727, TR3728, TR3729, TR3730, TR3731, TR3732, TR3733, TR3734, TR3735, TR3736, TR3737, TR3738, TR3739, TR3740, TR3741, TR3743, TR3744, TR3745, TR3746, TR3747, TR3748, TR3749, TR3750, TR3751, TR3752, TR3753, TR3754, TR3755, TR3756, TR3757, TR3758, TR3759, TR3760, TR3761, TR3762, TR3763, TR3764, TR3765, TR3766, TR3767, TR3768, TR3769, TR3770, TR3771, TR3772, TR3773, TR3774, TR3775, TR3776, TR3777, TR3778, TR3779, TR3780, TR3781, TR3782, TR3783, TR3784, TR3785, TR3786, TR3787, TR3788, TR3789, TR3790, TR3791, TR3792, TR3793, TR3794, TR3795, TR3796, TR3797, TR3798, TR3799, TR3800, TR3801, TR3802, TR3803, TR3804, TR3805, TR3806, TR3807, TR3808, TR3809, TR3810, TR3811, TR3812, TR3813, TR3814, TR3815, TR3816, TR3817, TR3818, TR3819, TR3820, TR3821, TR3822, TR3823, TR3824, TR3825, TR3826, TR3827, TR3828, TR3830, TR3831, TR3832, TR3833, TR3841R, TR3843, TR3844, TR3845, TR3846, TR3847, TR3848, TR3849, TR3850, TR3851, TR3852, TR3853, TR3854, TR3856, TR3857, TR3858, TR3859, TR3860, TR3861, TR3862, TR3863, TR3864, TR3865, TR3866, TR3867, TR3869, TR3870, TR3871, TR3872, TR3874, TR3875, TR3876, TR3877, TR3878, TR3879, TR3880, TR3881, TR3882, TR3883, TR3884, TR3885, TR3886, TR3887, TR3888, TR3889, TR3890, TR3891, TR3892, TR3893, TR3894, TR3895, TR3896, TR3897, TR3898, TR3899, TR3900, TR3901, TR3902, TR3903, TR3904, TR3905, TR3906, TR3907, TR3908, TR3909, TR3910, TR3911, TR3912, TR3913, TR3914, TR3915, TR3916, TR3917, TR3918, TR3919, TR3920, TR3921, TR3922, TR3923, TR3924, TR3925, TR3926, TR3927, TR3928, TR3929, TR3930, TR3931, TR3932, TR3933, TR3934, TR3935, TR3936, TR3937, TR3938, TR3939, TR3940, TR3941, TR3942, TR3943, TR3944, TR3945, TR3946, TR3947, TR3948, TR3949, TR3950, TR3951, TR3952, TR3953, TR3954, TR3955, TR3956, TR3957, TR3958, TR3959, TR3960, TR3961, TR3962, TR3963, TR3964, TR3965, TR3966, TR3967, TR3968, TR3969, TR3970, TR3971, TR3972, TR3973, TR3974, TR3975, TR3976, TR3977, TR3978, TR3979, TR3980, TR3981, TR3982, TR3983, TR3984, TR3985, TR3986, TR3987, TR3988, TR3989, TR3990, TR3991, TR3992, TR3993, TR3994, R3995R, TR3996, TR3997, TR3998, TR3999, TR4000, TR4001, TR4002, TR4003, TR4004, TR4005, TR4006, TR4007, TR4008, TR4009, TR4010, TR4011, TR4012, TR4013, TR4014, TR4015
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.
  • Description du dispositif
    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
  • Manufacturer
    WalkMed Infusion, LLC

Manufacturer

WalkMed Infusion, LLC
  • Adresse du fabricant
    WalkMed Infusion, LLC, 6555 S Kenton St Ste 304, Englewood CO 80111-6838
  • Société-mère du fabricant (2017)
    Walkmed Infusion LLC
  • Source
    USFDA