Class 2 Device Recall Triton Infusion Pump

• Date Initiated by Firm: June 14, 2016
• Date Posted: July 18, 2016
• Recall Status: Terminated on April 28, 2017
• Recall Number: Z-2219-2016
• Recall Event ID: 74436
• 510(K)Number: K070529
• Product Classification: Pump, infusion - Product Code FRN
• Product: The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
• Code Information: 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
• Recalling Firm/ Manufacturer: WalkMed Infusion, LLC; 6555 S Kenton St Ste 304; Englewood CO 80111-6838
• For Additional Information Contact: Sally Leonard; 303-420-9569
• Manufacturer Reason for Recall: 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).
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 2482 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = DEFINITIVE MEDICAL TECHNOLOGIES, LTD.