The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are pla...
FDA Device Recall #Z-2219-2016 — Class II — June 14, 2016
Recall Summary
| Recall Number | Z-2219-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 14, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | WalkMed Infusion, LLC |
| Location | Englewood, CO |
| Product Type | Devices |
| Quantity | 2482 units |
Product Description
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
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).
Distribution Pattern
Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.
Lot / 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
Other Recalls from WalkMed Infusion, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2228-2016 | Class II | T095-120 IV Set with 1.2 Micron Filter. Package... | Jun 14, 2016 |
| Z-2224-2016 | Class II | T090-000V 90" 20 Drop IV Admin Set w/ Needlefre... | Jun 14, 2016 |
| Z-2220-2016 | Class II | The pump (with cushioning foam inserts) is pack... | Jun 14, 2016 |
| Z-2235-2016 | Class II | T100-022WF, IV Set with 2 Y-Sites, 0.22 micron ... | Jun 14, 2016 |
| Z-2234-2016 | Class II | T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter ... | Jun 14, 2016 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.