Z-2219-2016Class II
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an...
WalkMed Technologies, LLC / initiated 2016-06-14 / Terminated / root cause: design
WalkMed Infusion, LLC began a recall of The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2219-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- WalkMed Technologies, 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.
- Product code
- FRN Pump, Infusion
- 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).
- Root cause tag
- design
- FDA 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 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.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2219-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2220-2016 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.