WalkMed Infusion, LLC: The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.

Recall number

Z-2219-2016

Recalling firm

WalkMed Infusion, LLC

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.

Status

Terminated

Initiated

2016-06-14

Posted

2016-07-18

Terminated

2017-04-28

Reason

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).

Root 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

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.

Lot, serial or model codes

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

510(k) numbers

["K070529"]

PMA numbers

not on file

Product code

FRN

Firm FEI

3000204189

Firm city

Englewood

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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