The Food and Drug Administration (FDA) clarifies that only the following affected Lots and Batches of Rüsch Endotracheal Tube are being voluntarily recalled by East lane Corporation.:
| Product Description | Product Code | Lot Numbers |
| Slick Set® Cuffed Endotracheal Tube and Stylet Set, oral/nasal
|
170050 | KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21C0488 |
| 170055 | KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21A0383, KME21A1901, KME21B2682, KME21C2708 | |
| 170060 | KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293 | |
| 170065 | KME20K0938, KME20K2623, KME20L0487, KME20L1705, KME20M1578, KME20M1751, KME20M2709, KME21A0385, KME21A1812, KME21B1670, KME21B2499, KME21B2500 | |
| 170070 | KME20K2544, KME20L0053, KME20L0055, KME20L0942, KME20L2372, KME20M0381, KME20M0665, KME20M1103, KME20M1754, KME20M1755, KME21A0893, KME21A2264, KME21B1074, KME21B1075, KME21C0463, KME21C0464, KME21C1027, KME21C1422, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 | |
| 170075 | KME20K1352, KME20L1132, KME20M0033, KME20M0382, KME20M1149, KME20M1225, KME20M1227, KME20M1537, KME20M2881, KME20M2882, KME21A0824, KME21A1161, KME21A1813, KME21B0813, KME21C0212, KME21C0213, KME21C1594, KME21C1895, KME21C2855, KME21C3294, KME21C3295 | |
| 170080 | KME20L0396, KME20L1278, KME20L1279, KME20L2830, KME20M0847, KME21A0386, KME21A2800, KME21A2801, KME21B1245, KME21B1752, KME21B2156, KME21C0465, KME21C0533, KME21C2826 | |
| 170085 | KME20L0398, KME20L2376, KME20M3247, KME21A1894, KME21C0298, KME21C2385 | |
| 170090 | KME20L0625 | |
| 170095 | KME20M0384, KME21B0407 | |
| Flexi-Set Cuffed Endotracheal Tube and Style Set, oral/nasal | 504550 | KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21A2076, KME21A2787, KME21B1140, KME21C0059, KME21C2363 |
| 504555 | KME20K0765, KME20K0766, KME20K0935, KME20K1582, KME20L0619, KME20L1857, KME20L2028, KME20M0020, KME21A1902, KME21A2796, KME21B2681, KME21C2707 | |
| 504560 | KME20K1550, KME20L0336, KME20L2298, KME20M0021, KME20M0492, KME21A0380, KME21A0817, KME21A1160, KME21A1770, KME21B1137, KME21B1138, KME21B1139, KME21C3255 | |
| 504565 | KME20K0465, KME20K0939, KME20K1551, KME20K1628, KME20K2246, KME20L0488, KME20L1840, KME20M0022, KME20M0854, KME20M1102, KME20M1579, KME21A0085, KME21A1040, KME21A1292, KME21A2794, KME21B1141, KME21B1669, KME21B2155, KME21B2501, KME21B2502, KME21B2855, KME21C0025, KME21C1202, KME21C1331, KME21C1790, KME21C1897, KME21C2188, KME21C2262, KME21C2835 | |
| Flexi-Set Cuffed Endotracheal Tube and Style Set, oral/nasal | 504570 | KME20K0026, KME20K0360, KME20K0361, KME20K0768, KME20K0941, KME20K1148, KME20K1202, KME20K1304, KME20K1552, KME20K1658, KME20K2057, KME20K2187, KME20K3161, KME20K3355, KME20L0057, KME20L0059, KME20L0490, KME20L0623, KME20L0943, KME20L0944, KME20L1091, KME20L1122, KME20L1124, KME20L1475, KME20L1844, KME20L2039, KME20L2258, KME20L2827, KME20M0378, KME20M0379, KME20M0380, KME20M0498, KME20M1105, KME20M1153, KME20M1156, KME21A0228, KME21A0273, KME21A0304, KME21A0305, KME21A1769, KME21A2227, KME21A2228, KME21A2229, KME21A2263, KME21A3119, KME21A3120, KME21A3121, KME21B0261, KME21B0338, KME21B0559, KME21B0750, KME21B1073, KME21B1751, KME21B2107, KME21B2153, KME21B2460, KME21B2719, KME21B2721, KME21C0123, KME21C0376, KME21C0421, KME21C0620, KME21C0634, KME21C1016, KME21C1333, KME21C1416, KME21C1434, KME21C1489, KME21C1593, KME21C1653, KME21C1703, KME21C1786, KME21C1896, KME21C2065, KME21C2146 |
| 504575 | KME20K0769, KME20K0770, KME20K1150, KME20K1204, KME20K1665, KME20K2188, KME20K2920, KME20K3016, KME20K3018, KME20K3159, KME20K3575, KME20L1476, KME20L2374, KME20M0383, KME20M1151, KME20M2051, KME20M2344, KME20M2376, KME20M2485, KME20M2556, KME21A0084, KME21A0303, KME21A0671, KME21A0672, KME21A0673, KME21A0674, KME21A0812, KME21A1041, KME21A1464, KME21A1605, KME21A2799, KME21A2815, KME21B0753, KME21B0814, KME21B0888, KME21B0889, KME21B0931, KME21B1240, KME21B2461, KME21B2462, KME21B2465, KME21B2716, KME21B2717, KME21C0700, KME21C0972, KME21C1203, KME21C1336, KME21C1435, KME21C1893, KME21C2565, KME21C2610 | |
| Flexi-Set Cuffed Endotracheal Tube and Style Set, oral/nasal | 504580 | KME20K0449, KME20K0450, KME20K1414, KME20K2622, KME20L1277, KME20L1479, KME20L2302, KME20L2828, KME20M1752, KME20M1753, KME21A0381, KME21A0820, KME21A0823, KME21A1291, KME21A1604, KME21B0339, KME21B1241, KME21B1855, KME21B2108, KME21B2154, KME21B2697, KME21C0377, KME21C0623, KME21C2407, KME21C2738, KME21C3448 |
| 504585 | KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21A0891, KME21A1043, KME21A2802, KME21A2803, KME21B0933, KME21B1250, KME21B1251, KME21B2029, KME21C0506, KME21C2107, KME21C2339, KME21C2341, KME21C2553, KME21D0210 | |
| 504590 | KME20L0626, KME20M0856, KME20M2091, KME21C0299, KME21C2104, KME21C2105 | |
| Endotracheal Tube – with cuff – Murphy – Sterile pack | 07802 | KME20K1277 |
| 07803 | KME20K1379 | |
| 07804 | KME20K1278 | |
| 07805 | KME20K1279 | |
| 07806 | KME20K1280 | |
| 07807 | KME20K1281 | |
| Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff | 112080050 | KME20K1512, KME20L1145, KME20M2383, KME21B0357 |
| 112080055 | KME20K2579, KME21A2569, KME21C1978 | |
| 112080060 | KME20M0616, KME20M2112, KME21A2685 | |
| 112080065 | KME20K2581, KME21C1701 | |
| 112080070 | KME20K2577, KME20L1985, KME20M1771, KME20M1772, KME20M2856, KME21A2355, KME21B1624, KME21B2490, KME21C1184 | |
| 112080075 | KME20K0110 | |
| 112080080 | KME20M0377, KME21B2727, KME21C0500 | |
| 112080085 | KME20M0909, KME21B0519, KME21C0067 | |
| 112080090 | KME20K1808, KME20L2352, KME20M2248 | |
| 112080095 | KME20K2310, KME20L1153 | |
| 112080100 | KME20K1005, KME20L1144 | |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff | 112082050 | KME20K0211, KME20K0463, KME21A2017, KME21A2343, KME21A2686, KME21B2491 |
| 112082055 | KME20K0464, KME20K0683, KME20L1703, KME20M0996, KME21A0492, KME21A1433, KME21C0502, KME21C1347, KME21C1496, KME21C2745, KME21D0835 | |
| 112082060 | KME20K0435, KME20K1112, KME20K2168, KME20K3530, KME20L0196, KME20L1143, KME20L1420, KME20L2089, KME20L2783, KME20M0497, KME20M0663, KME20M1064, KME20M1143, KME20M1218, KME21A1521, KME21A1803, KME21A2066, KME21A2344, KME21B0252, KME21B1151, KME21B1592, KME21B2606, KME21B2729, KME21C0483, KME21C1094, KME21C2681, KME21C2996, KME21D0703, KME21D1159, KME21D1326 | |
| 112082065 | KME20K0036, KME20K0259, KME20K0436, KME20K050, KME20K0677, KME20K0881, KME20L1421, KME20L1436, KME20L2349, KME20L2447, KME20L2448, KME20M0710, KME20M0892, KME20M0928, KME20M1806, KME20M1923, KME20M2249, KME20M2450, KME20M2708, KME21A0338, KME21A0404, KME21A0695, KME21A1588, KME21A1779, KME21A2102, KME21A2230, KME21A2572, KME21B1352, KME21B2607, KME21B2789, KME21B2856, KME21C0504, KME21C0981, KME21C0983, KME21C1035, KME21C1036, KME21C1097, KME21C1925, KME21C2997, KME21C3166, KME21C3456 | |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff | 112082070 | KME20J2802, KME20K0061, KME20K0437, KME20K0462, KME20K0585, KME20K1007, KME20K3013, KME20K3014, KME20K3145, KME20K3365, KME20K3448, KME20K3518, KME20K3560, KME20L0276, KME20L0371, KME20L0785, KME20L0928, KME20L1691, KME20L1752, KME20L1858, KME20L1874, KME20L1923, KME20L2111, KME20L2210, KME20L2273, KME20L2350, KME20L2373, KME20L2463, KME20L2478, KME20L2499, KME20L2699, KME20L2826, KME20M0490, KME20M0664, KME20M0712, KME20M0762, KME20M0774, KME20M0839, KME21A1121, KME21A1215, KME21A1328, KME21A2220, KME21A2345, KME21A2574, KME21A2984, KME21A3038, KME21B0136, KME21B0711, KME21B2898, KME21C0505, KME21C0567, KME21C0701, KME21C0737, KME21C0822, KME21C0854, KME21C0971, KME21C0973, KME21C1279, KME21C1328, KME21C1655, KME21C1702, KME21C2150, KME21C2403, KME21C2568, KME21C2875, KME21C2954, KME21D0350, KME21D0435, KME21D0491, KME21D0714, KME21D0715, KME21D1218, KME21D1409 |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff | 112082075 | KME20J3284, KME20K0052, KME20K0181, KME20K1113, KME20K3044, KME20K3577, KME20L0484, KME20L0755, KME20L1092, KME20L1156, KME20L1298, KME20L1299, KME20L1704, KME20L1924, KME20L1983, KME20L2605, KME20L2798, KME20M0034, KME20M0321, KME20M1067, KME20M1507, KME20M1890, KME20M2212, KME21A3004, KME21A3259, KME21B0179, KME21B0823, KME21B2480, KME21B2482, KME21C0239, KME21C0264, KME21C0614, KME21C0615, KME21C0661, KME21C0702, KME21C0730, KME21C0826, KME21C0855, KME21C1093, KME21C1223, KME21C1323, KME21C1399, KME21C1601, KME21C1704, KME21C1746, KME21C1944, KME21C2008, KME21C2026, KME21C2051, KME21C2066, KME21C2195, KME21C2499, KME21C2615, KME21C2680, KME21C2766, KME21C2908, KME21C2964, KME21C3394, KME21D0029, KME21D0058, KME21D0186, KME21D0586, KME21D0648, KME21D0775, KME21D1103, KME21D1400, KME21D1423 |
| 112082080 | KME20J2998, KME20J3341, KME20K3520, KME20L0194, KME20L1157, KME20L1237, KME20L1706, KME20L2207, KME20L2333, KME20L2375, KME20L2607, KME20L2696, KME20M0577, KME20M1043, KME20M1069, KME20M1260, KME20M1342, KME20M1780, KME20M2363, KME21A0082, KME21A1435, KME21A1522, KME21A1524, KME21A2014, KME21A2058, KME21A2576, KME21B0049, KME21B0137, KME21B0248, KME21B0428, KME21B0616, KME21B0709, KME21B0863, KME21B1214, KME21B1284, KME21B2488, KME21B2489, KME21C0705, KME21C0706, KME21C1063, KME21C1325, KME21C1441, KME21C1745, KME21C1785, KME21C2068, KME21C3283, KME21C3320 | |
| Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff | 112082085 | KME20J2999, KME20K0923, KME20K1114, KME20K1273, KME20K1513, KME20K3020, KME20K3034, KME20K3146, KME20L0670, KME20L0756, KME20L0757, KME20L1437, KME20L1549, KME20L1678, KME20L1707, KME20L1867, KME20L2274, KME20L2831, KME20M1511, KME20M1548, KME20M1849, KME20M3122, KME20M3248, KME21A0697, KME21A1093, KME21A2265, KME21A2577, KME21B0932, KME21B0958, KME21B1215, KME21C3024, KME21C3324, KME21D0061 |
| 112082090 | KME20K0180, KME20K0212, KME20K0600, KME20K0978, KME20K1434, KME20K3021, KME20K3525, KME20L0805, KME20L1142, KME21A2016, KME21A2676, KME21A3263, KME21B0632, KME21B1283 | |
| 112082095 | KME20K1583, KME20K1831, KME20K2166, KME20K2574, KME20L1041, KME20L1592, KME20L2462, KME20L2557, KME20M2115, KME20M2198, KME21A2346, KME21A3264, KME21B1895, KME21C3326 | |
| 112082100 | KME20K0977, KME20K1809, KME20K2553, KME20L0335, KME20M1341, KME20M2113, KME21A2342, KME21A2668, KME21C0017, KME21C0068, KME21D0827, KME21D1219 | |
| Ruschelit® Safety Clear Plus Tracheal Tube, oral/nasal, cuffed | 112080-000055 | KME21C1977 |
| 112080-000060 | KME20M0614, KME21A2570 | |
| 112080-000065 | KME20M0233 | |
| 112080-000070 | KME20K2219, KME20L1984, KME20M2855, KME21D0826 | |
| 112080-000075 | KME20K3531, KME20M0511, KME20M2857 | |
| 112080-000080 | KME20L0174, KME20M0376, KME20M2197, KME20M2865, KME21A2808, KME21B1150, KME21B2728, KME21C0501, KME21C1185, KME21C3319 | |
| 112080-000090 | KME20K3532, KME20K3670, KME20L2623, KME20M0777 | |
| 112080-000095 | KME20L1152 | |
| 112082-000050 | KME20K2560, KME20L0855 | |
| 112082-000055 | KME20K0434, KME20K0598, KME20K1036, KME20L1986, KME20M0997, KME21A0757, KME21A1434, KME21C2746 | |
| 112082-000060 | KME20K0206, KME20K0746, KME20K1008, KME20K1182, KME20K1412, KME20K1733, KME20K3529, KME20M1257, KME21A2055, KME21B2605, KME21D1158 | |
| 112082-000065 | KME20J3330, KME20K0207, KME20K0957, KME20K1023, KME20K1153, KME20K1212, KME20K1413, KME20K1558, KME20K2352, KME20K3556, KME20L1238, KME20M0711, KME20M1924, KME20M2114, KME21A0921, KME21A2571, KME21A3003, KME21B2551, KME21B2788, KME21C0070, KME21C0503, KME21C0984, KME21C1098, KME21C1230, KME21C3455 | |
| 112082-000070 | KME20K0198, KME20K0199, KME20K0260, KME20K0732, KME20K0747, KME20K0800, KME20K0871, KME20K0958, KME20K0976, KME20K1101, KME20K1274, KME20K1480, KME20K1559, KME20K1660, KME20K2179, KME20K2226, KME20K2306, KME20K2327, KME20K2351, KME20K2490, KME20L1151, KME20L2074, KME20L2198, KME20L2700, KME20M0489, KME20M0840, KME20M1018, KME20M1019, KME20M1044, KME20M1700, KME20M3246, KME21A0080, KME21A0339, KME21A0495, KME21A0732, KME21A0733, KME21A0863, KME21A1329, KME21A1802, KME21A2573, KME21A2780, KME21B0514, KME21B0792, KME21B1282, KME21B1593, KME21B2095, KME21B2608, KME21B2850, KME21B2851, KME21C1096, KME21C1191, KME21C1914, KME21C2067, KME21C2519, KME21C2520, KME21C2747, KME21C2953 | |
| Ruschelit® Safety Clear Plus Tracheal Tube, oral/nasal, cuffed | 112082-000075 | KME20J3329, KME20K0182, KME20K0208, KME20K0599, KME20K0705, KME20K0734, KME20K1122, KME20K1183, KME20K1222, KME20K1236, KME20K1349, KME20K1410, KME20K1529, KME20K1555, KME20K1763, KME20K1858, KME20K2103, KME20K2319, KME20L1155, KME20L1692, KME20L1753, KME20L2740, KME20M0180, KME20M0448, KME20M0496, KME20M0612, KME20M1152, KME20M2213, KME20M2606, KME20M2774, KME20M2993, KME20M3120, KME20M3121, KME20M3245, KME20M3317, KME21A0583, KME21A2077, KME21A2575, KME21A2678, KME21A2795, KME21A2983, KME21A3122, KME21A3123, KME21B2092, KME21B2093, KME21B2604, KME21B2651, KME21B2786, KME21C0066, KME21C0236, KME21C0825, KME21C1225, KME21C1379, KME21C2613, KME21C2845, KME21C3302, KME21D0323, KME21D0436, KME21D0504, KME21D0773 |
| 112082-000080 | KME20J2949, KME20K0711, KME20K0748, KME20K1037, KME20K1123, KME20K1137, KME20K1176, KME20K1181, KME20K1230, KME20K1275, KME20K1356, KME20K1411, KME20K1509, KME20K1556, KME20K1638, KME20K1743, KME20K2023, KME20K3035, KME20K3125, KME20K3478, KME20L2076, KME20L2697, KME20L2698, KME20L2799, KME20M0578, KME20M2366, KME21A0342, KME21A1223, KME21A1288, KME21A1289, KME21A2059, KME21A3260, KME21A3261, KME21B0238, KME21B0865, KME21B1213, KME21B2487, KME21C0731, KME21C0828, KME21C0886, KME21C1192, KME21C1208, KME21C1324, KME21C2998, KME21C3113, KME21C3114 | |
| Ruschelit® Safety Clear Plus Tracheal Tube, oral/nasal, cuffed | 112082-000085 | KME20K0168, KME20K0261, KME20K0749, KME20K1044, KME20K1213, KME20K1215, KME20K1276, KME20K1417, KME20K1530, KME20K1661, KME20K1702, KME20L2351, KME20M1510, KME21D0060 |
| 112082-000090 | KME21A2015, KME21A3262 | |
| 112082-000100 | KME20M1340 | |
| Ruschelit® Super Safety Clear Tracheal Tube, oral/nasal, cuffed
|
112480-000050 | KME20M3309, KME21A2073, KME21A2995, KME21A2996, KME21B1192, KME21C3174, KME21D0829 |
| 112480-000055 | KME21A2563, KME21A2605, KME21B0980, KME21C0291, KME21D1120, KME21D1121 | |
| 112480-000060 | KME20M2727, KME21A1424, KME21A2300, KME21A2301, KME21A2997, KME21B0162, KME21C0292, KME21C1156, KME21D1463, KME21D1466 | |
| 112480-000065 | KME20M3108, KME21A2249, KME21B0356, KME21B1982, KME21B2165, KME21B2578, KME21B2655, KME21C1980, KME21C3328, KME21D0028, KME21D0321, KME21D0437, KME21D0505, KME21D0627, KME21D0716, KME21D0761, KME21D0844 | |
| 112480-000070 | KME21A0396, KME21A0859, KME21A1089, KME21A1274, KME21A1341, KME21A1607, KME21A1612, KME21A1781, KME21A1804, KME21A2177, KME21A2521, KME21A2718, KME21A2888, KME21A2982, KME21A2998, KME21A3053, KME21A3195, KME21B0050, KME21B0141, KME21B0375, KME21B0419, KME21B0502, KME21B0517, KME21B0617, KME21B0835, KME21B0959, KME21B1020, KME21B1285, KME21B1527, KME21B1636, KME21B1844, KME21B1945, KME21B2005, KME21B2098, KME21B2164, KME21B2653, KME21B2723, KME21B2895, KME21C0086, KME21C0402, KME21C0662, KME21C0768, KME21C0786, KME21C0932, KME21C1037, KME21C3396, KME21D0187, KME21D0438, KME21D0515, KME21D0833, KME21D0926, KME21D0970, KME21D0991, KME21D1040, KME21D1155, KME21D1467 | |
| 112480-000075 | KME21A1103, KME21A1104, KME21A1525, KME21A1580, KME21A2103, KME21A2358, KME21A2475, KME21A2606, KME21A2716, KME21A2777, KME21A2942, KME21A2999, KME21A3196, KME21A3199, KME21B0285, KME21B0344, KME21B0515, KME21B0981, KME21B1115, KME21B1152, KME21B1209, KME21B1281, KME21B1349, KME21B1591, KME21B1653, KME21B1684, KME21B1740, KME21B1791, KME21B1821, KME21B1896, KME21B2073, KME21B2323, KME21B2650, KME21B2806, KME21C0309, KME21C0436, KME21C0439, KME21C0569, KME21C0630, KME21C0703, KME21C0787, KME21C0933, KME21C0985, KME21C1384, KME21C1657, KME21C1809, KME21C1966, KME21C2705, KME21C3315, KME21C3429, KME21D0035, KME21D0226, KME21D0439, KME21D0583, KME21D0675, KME21D1156, KME21D1221, KME21D1303, KME21D1433, KME21D1469 | |
| Ruschelit® Super Safety Clear Tracheal Tube, oral/nasal, cuffed | 112480-000080 | KME21A1455, KME21A1528, KME21A2035, KME21A2061, KME21A2141, KME21A2473, KME21A2474, KME21A2664, KME21A2724, KME21A3242, KME21B0163, KME21B0192, KME21B0239, KME21B0345, KME21B0791, KME21B0809, KME21B0960, KME21B1116, KME21B1153, KME21B1687, KME21B1965, KME21B2168, KME21B2324, KME21B2547, KME21B2724, KME21C1395, KME21C1629, KME21C2070, KME21C2436, KME21C2569, KME21C2763, KME21C2846, KME21C2874, KME21C3025, KME21C3175, KME21C3206, KME21D0067, KME21D0561, KME21D0717, KME21D0845, KME21D1116 |
| 112480-000085 | KME21A1805, KME21A2340, KME21A2472, KME21A2526, KME21B0982, KME21B1035, KME21B1279, KME21B1650, KME21B2857, KME21B2896, KME21B2929, KME21C1901, KME21D1252, KME21D1401, KME21D1484 | |
| 112480-000090 | KME21A1275, KME21A1806, KME21A2062, KME21A3072, KME21C0265, KME21C0556, KME21C0868, KME21C1808, KME21C1900, KME21C2664, KME21D1538 | |
| 112480-000095 | KME21C2671 | |
| 112480-000100 | KME21A2687, KME21B0979, KME21B1212, KME21B1277, KME21C1207, KME21D0590, KME21D0925 | |
| Ruschelit® Super Safety Clear Tracheal Tube, oral/nasal, cuffed | 112482-000050 | KME21A0753, KME21A1152, KME21A1280, KME21A2564, KME21A3116, KME21B0550, KME21B1155, KME21B1255, KME21B1818, KME21B1901, KME21B2169, KME21B2546, KME21B2858, KME21C0065, KME21C0181, KME21C0183, KME21C0185, KME21C2824, KME21D0137, KME21D0185, KME21D0322, KME21D0644, KME21D0712 |
| 112482-000055 | KME21A0395, KME21A0638, KME21A1153, KME21A1879, KME21A2143, KME21A2565, KME21A3000, KME21B0422, KME21B0710, KME21B1590, KME21B1819, KME21B1902, KME21B2257, KME21B2820, KME21B2927, KME21C0499, KME21C0631, KME21C1326, KME21C2825, KME21C3168, KME21C3207, KME21C3325, KME21D0138, KME21D0212, KME21D0503, KME21D1476 | |
| 112482-000060 | KME21A1021, KME21A1022, KME21A1276, KME21A2013, KME21A2730, KME21A3254, KME21B0060, KME21B1271, KME21B1626, KME21B1744, KME21B1944, KME21B2166, KME21C0071, KME21C0364, KME21C0484, KME21C1329, KME21C1443, KME21C2189, KME21C2397, KME21C2437, KME21C3169, KME21D0410, KME21D0990, KME21D1036, KME21D1152, KME21D1251, KME21D1464, KME21D1465 | |
| 112482-000065 | KME20M2668, KME21A0919, KME21A1023, KME21A1107, KME21A1277, KME21A1814, KME21A1916, KME21A1938, KME21A2169, KME21A2470, KME21A2663, KME21A3078, KME21A3255, KME21B1185, KME21B1256, KME21B1273, KME21B1718, KME21B1741, KME21B1814, KME21B2002, KME21B2096, KME21B2167, KME21B2260, KME21B2545, KME21B2725, KME21C0009, KME21C0363, KME21C1227, KME21C1388, KME21C1479, KME21C1600, KME21C1747, KME21C1748, KME21C1899, KME21C2139, KME21C2286, KME21C2398, KME21C2492, KME21C2909, KME21C3027, KME21C3054, KME21C3145, KME21C3170, KME21C3430, KME21C3454, KME21C3517, KME21D0057, KME21D0345, KME21D0489, KME21D0633, KME21D0713, KME21D1118, KME21D1250 | |
| Ruschelit® Super Safety Clear Tracheal Tube, oral/nasal, cuffed | 112482-000070 | KME21A0600, KME21A0860, KME21A0861, KME21A0918, KME21A0982, KME21A1105, KME21A1278, KME21A1290, KME21A1412, KME21A1425, KME21A1490, KME21A1501, KME21A1584, KME21A1696, KME21A1860, KME21A1861, KME21A2219, KME21A2262, KME21A2469, KME21A2527, KME21A2705, KME21A2706, KME21A2769, KME21A2839, KME21A2889, KME21A3077, KME21A3192, KME21A3209, KME21A3224, KME21B0023, KME21B0139, KME21B0203, KME21B0237, KME21B0286, KME21B0287, KME21B0346, KME21B0368, KME21B0423, KME21B0615, KME21B0758, KME21B0762, KME21B0811, KME21B0857, KME21B1024, KME21B1105, KME21B1257, KME21B1274, KME21B1565, KME21B1691, KME21B1719, KME21B1820, KME21B1999, KME21B2171, KME21B2473, KME21B2548, KME21B2549, KME21B2695, KME21B2696, KME21B2726, KME21B2790, KME21B2897, KME21C0007, KME21C0735, KME21C0856, KME21C0964, KME21C1038, KME21C1193, KME21C1317, KME21C1477, KME21C1495, KME21C1654, KME21C1705, KME21C1744, KME21C1791, KME21C1967, KME21C2069, KME21C2140, KME21C2179, KME21C2220, KME21C2288, KME21C2322, KME21C2354, KME21C2399, KME21C2438, KME21C2570, KME21C2617, KME21C2699, KME21C2709, KME21C3146, KME21C3171, KME21C3284, KME21C3431, KME21C3453, KME21D0017, KME21D0039, KME21D0181, KME21D0230, KME21D0320, KME21D0344, KME21D0434, KME21D0516, KME21D0562, KME21D0585, KME21D0642, KME21D0657, KME21D0710, KME21D0759, KME21D0923, KME21D0983, KME21D0993, KME21D1032, KME21D1117, KME21D1151, KME21D1277, KME21D1305, KME21D1424, KME21D1535 |
| Ruschelit® Super Safety Clear Tracheal Tube, oral/nasal, cuffed | 112482-000075 | KME21A0267, KME21A0694, KME21A0731, KME21A0924, KME21A0926, KME21A0984, KME21A1106, KME21A1154, KME21A1251, KME21A1330, KME21A1395, KME21A1426, KME21A1460, KME21A1467, KME21A1526, KME21A1697, KME21A1782, KME21A1878, KME21A1915, KME21A1939, KME21A1942, KME21A2034, KME21A2176, KME21A2213, KME21A2456, KME21A2608, KME21A2786, KME21A2788, KME21A2841, KME21A2890, KME21A2938, KME21A3001, KME21A3185, KME21A3190, KME21B0191, KME21B0424, KME21B0479, KME21B0512, KME21B0614, KME21B0707, KME21B0708, KME21B0806, KME21B0812, KME21B0859, KME21B0961, KME21B1025, KME21B1112, KME21B1156, KME21B1567, KME21B1622, KME21B1742, KME21B1897, KME21B1966, KME21B2008, KME21B2256, KME21B2456, KME21B2577, KME21B2657, KME21B2720, KME21B2818, KME21B2860, KME21C0015, KME21C0088, KME21C0266, KME21C0310, KME21C0362, KME21C0408, KME21C0485, KME21C0613, KME21C0699, KME21C0729, KME21C0736, KME21C0866, KME21C0934, KME21C1029, KME21C1229, KME21C1332, KME21C1380, KME21C1381, KME21C1439, KME21C1454, KME21C1586, KME21C1599, KME21C1681, KME21C1810, KME21C1964, KME21C2024, KME21C2153, KME21C2289, KME21C2355, KME21C2400, KME21C2439, KME21C2491, KME21C2566, KME21C2710, KME21C3172, KME21C3267, KME21C3285, KME21C3300, KME21C3392, KME21C3432, KME21C3476, KME21C3518, KME21D0068, KME21D0166, KME21D0304, KME21D0337, KME21D0490, KME21D0574, KME21D0646, KME21D0689, KME21D0757, KME21D0830, KME21D0843, KME21D0919, KME21D0985, KME21D1037, KME21D1071, KME21D1102, KME21D1150, KME21D1248, KME21D1272, KME21D1289, KME21D1304, KME21D1411, KME21D1486, KME21D1525, KME21D1533 |
| Ruschelit® Super Safety Clear Tracheal Tube, oral/nasal, cuffed | 112482-000080 | KME21A0394, KME21A0635, KME21A0737, KME21A0985, KME21A1018, KME21A1091, KME21A1098, KME21A1157, KME21A1394, KME21A1427, KME21A1428, KME21A1479, KME21A1581, KME21A1760, KME21A1801, KME21A1877, KME21A1943, KME21A2011, KME21A2057, KME21A2174, KME21A2175, KME21A2466, KME21A2529, KME21A2611, KME21A2731, KME21A2843, KME21A2892, KME21A3071, KME21A3114, KME21A3115, KME21A3193, KME21A3257, KME21B0156, KME21B0292, KME21B0501, KME21B0511, KME21B0629, KME21B0756, KME21B0764, KME21B1036, KME21B1275, KME21B1528, KME21B1564, KME21B1632, KME21B1743, KME21B1817, KME21B1943, KME21B2050, KME21B2088, KME21B2094, KME21B2694, KME21B2718, KME21B2785, KME21C0005, KME21C0087, KME21C0308, KME21C0407, KME21C0444, KME21C0568, KME21C0632, KME21C0666, KME21C0911, KME21C0966, KME21C1039, KME21C1182, KME21C1205, KME21C1226, KME21C1394, KME21C1455, KME21C1476, KME21C1635, KME21C1706, KME21C1782, KME21C1846, KME21C1902, KME21C2193, KME21C2440, KME21C2493, KME21C2571, KME21C2616, KME21C2638, KME21C2678, KME21C2768, KME21C2769, KME21C3051, KME21C3111, KME21C3301, KME21C3318, KME21C3393, KME21D0019, KME21D0165, KME21D0229, KME21D0305, KME21D0341, KME21D0760, KME21D0928, KME21D0968, KME21D0989, KME21D1410, KME21D1534 |
| Ruschelit® Super Safety Clear Tracheal Tube, oral/nasal, cuffed | 112482-000085 | KME21A1158, KME21A1253, KME21A1340, KME21A1429, KME21A2178, KME21A3002, KME21B0425, KME21B0516, KME21B0836, KME21B0883, KME21B1019, KME21B1258, KME21B1344, KME21B1634, KME21B2097, KME21B2476, KME21B2652, KME21C1206, KME21C1700, KME21C2267, KME21C2338, KME21C2356, KME21C2402, KME21C2498, KME21C2521, KME21C2618, KME21C2829, KME21C2873, KME21D0411, KME21D0718, KME21D0847, KME21D0992, KME21D1154 |
| 112482-000090 | KME21A0959, KME21A2339, KME21A2567, KME21A2732, KME21B1816, KME21B2074, KME21B2255, KME21C1783, KME21C2642, KME21C2679, KME21C2722, KME21C2818, KME21D0412, KME21D0492 | |
| 112482-000095 | KME20M1932, KME21A0607, KME21A2232, KME21A2233, KME21A2943, KME21C0072, KME21C3327, KME21C3435, KME21D0413 | |
| 112482-000100 | KME21A2729, KME21A3243, KME21B0967, KME21B1254, KME21B2326, KME21D0587, KME21D0969, KME21D1133, KME21D1223, KME21D1224 | |
| 112482050LA | KME21D0184 | |
| 112482055LA | KME21C0591, KME21D1270 | |
| 112482060LA | KME21C1442, KME21C2959 | |
| 112482065LA | KME20M1333, KME21C3026 | |
| 112482070LA | KME21B1898, KME21B1959, KME21B1998, KME21B2048, KME21C2847, KME21C3052, KME21C3110 | |
| 112482075LA | KME20M0908, KME21B2049, KME21B2576, KME21C2828, KME21C2995, KME21C3018, KME21C3071, KME21C3107, KME21C3269 | |
| 112482080LA | KME20M0891, KME21B2472, KME21B2648, KME21C2721, KME21C2787, KME21C2910, KME21C2988, KME21C3028 | |
| 112482085LA | KME21B1900, KME21B2475, KME21C2958, KME21D0183, KME21D0306, KME21D0758, KME21D0922, KME21D1039 | |
| 112482090LA | KME21D0182, KME21D0878, KME21D0987 | |
| 112482095LA | KME21C0867 | |
| Super Safety Clear Flexiset Tracheal tube, oral/nasal, with cuff and insertion aid
|
112481-000050 | 20DT14, 20DT29, 20DT37, 20ET08, 20FT10, 20FT18, 20GT25, KME20H0523, KME20H1286, KME20H1940, KME20H3040, KME20J2865, KME20J3125, KME20K3588, KME20M0842, KME21A2789, KME21A2790, KME21C0016, KME21C1975, KME21C1976, KME21D0625, KME21D1080 |
| 112481-000055 | 20DT37, 20FT39, 20GT06, KME20H2241, KME20H2784, KME20H3041, KME20K0161, KME20K0162, KME20K0760, KME20L1489, KME20M0790, KME20M3271, KME21A2792, KME21C1183, KME21C1195, KME21C2740 | |
| 112481-000060 | 20ET04, 20ET08, 20ET37, 20FT10, 20FT23, KME20H0135, KME20H0136, KME20H0971, KME20H1931, KME20H2245, KME20J1930, KME20J1931, KME20J2866, KME20K1343, KME20K3147, KME20K3583, KME20L2370, KME20M2050, KME20M2374, KME21C2546, KME21D0697 | |
| 112481-000065 | 20ET08, 20ET37, 20ET56, 20FT10, 20FT35, 20GT14, 20GT49, KME20G0187, KME20H2247, KME20H2786, KME20K0761, KME20K0762, KME20K0763, KME20K3570, KME20M0660, KME20M0799, KME20M2371, KME20M2876, KME20M3272, KME21A2797, KME21A3117, KME21B2280, KME21B2281, KME21B2282, KME21B2699, KME21C2850, KME21C2853, KME21D0595, KME21D1019 | |
| 112481-000070 | 20DT22, 20ET08, 20ET37, 20ET49, 20FT18, 20FT39, 20FT44, 20FT61, 20FT65, 20GG41, 20GG45, 20GT06, 20GT14, 20GT25, 20GT31, KME20G0054, KME20H0252, KME20H0384, KME20H0778, KME20H1938, KME20H1939, KME20H2154, KME20H3042, KME20H3043, KME20J1577, KME20J1689, KME20J2867, KME20J2868, KME20J3013, KME20J3038, KME20J3128, KME20J3129, KME20J3130, KME20K0149, KME20K1756, KME20K2461, KME20K2875, KME20K3105, KME20K3164, KME20L1276, KME20L2824, KME20M1942, KME20M1943, KME20M2875, KME21A0362, KME21A0364, KME21A1527, KME21A1536, KME21A1537, KME21A1944, KME21A1945, KME21A2142, KME21A2838, KME21A3256, KME21B0394, KME21B1248, KME21B2398, KME21C1196, KME21C1917, KME21C2035, KME21C2543, KME21C3105, KME21C3314, KME21D0698, KME21D0960, KME21D1081 | |
| Super Safety Clear Flexiset Tracheal tube, oral/nasal, with cuff and insertion aid | 112481-000075 | 20DT09, 20DT22, 20DT29, 20ET08, 20ET37, 20ET49, 20FT18, 20FT23, 20FT44, 20FT54, 20FT61, 20FT65, 20GT06, 20GT14, 20GT25, 20GT38, KME20G0055, KME20G0188, KME20H2248, KME20J1581, KME20J1583, KME20J1933, KME20J2423, KME20J2424, KME20J2425, KME20J2980, KME20J3132, KME20J3133, KME20J3135, KME20K0023, KME20K0120, KME20K0150, KME20K1757, KME20K2463, KME20K2876, KME20K3002, KME20K3003, KME20L0180, KME20L0622, KME20L1871, KME20L2218, KME20L2300, KME20L2301, KME20M0800, KME20M1107, KME20M1251, KME20M2582, KME21A0226, KME21A2338, KME21A2840, KME21A3118, KME21B1249, KME21B1872, KME21B2028, KME21B2859, KME21C0452, KME21C1197, KME21C2151, KME21C2544, KME21C3359, KME21C3390, KME21D0699 |
| 112481-000080 | 20DT14, 20DT22, 20ET04, 20ET08, 20ET21, 20ET28, 20ET37, 20ET39, 20ET49, 20FT10, 20FT39, 20FT44, 20FT61, 20GT06, 20GT14, 20GT25, 20GT31, 20GT49, KME20G0243, KME20G0244, KME20G0245, KME20G0382, KME20G0392, KME20G0394, KME20G0396, KME20G0397, KME20H0380, KME20H0381, KME20H0387, KME20H0524, KME20H0525, KME20H0526, KME20H0527, KME20H0528, KME20H0529, KME20H0530, KME20H0779, KME20H1542, KME20H1543, KME20H1652, KME20H1792, KME20H1936, KME20H1937, KME20H2249, KME20H2250, KME20J0158, KME20J1697, KME20J1698, KME20J2181, KME20J2183, KME20J2403, KME20J2870, KME20K0024, KME20K0025, KME20K0362, KME20K1758, KME20K2251, KME20K2252, KME20K2364, KME20K3005, KME20K3354, KME20K3567, KME20L0181, KME20L2219, KME20L2257, KME21A1293, KME21A1323, KME21A1325, KME21A2144, KME21A2145, KME21A2510, KME21A2842, KME21A3112, KME21B0395, KME21B1899, KME21B1938, KME21B2279, KME21B2355, KME21C0750, KME21C1169, KME21C1170, KME21C2034, KME21C2071 | |
| Super Safety Clear Flexiset Tracheal tube, oral/nasal, with cuff and insertion aid | 112481-000085 | 20DT14, 20DT29, 20ET08, 20ET37, 20FT10, 20FT44, 20FT54, 20FT65, 20GT25, 20GT38, KME20H1103, KME20J1578, KME20J1579, KME20J2255, KME20J2256, KME20K2189, KME20K2368, KME20K2505, KME20K2921, KME20K3107, KME20K3150, KME20K3568, KME20L1474, KME20L2031, KME20L2729, KME20M2370, KME20M2484, KME20M3251, KME20M3252, KME21A0187, KME21A2357, KME21B0340, KME21B1252, KME21B2030, KME21C1595, KME21C1597 |
| 112481-000090 | KME21A0753, KME21A1152, KME21A1280, KME21A2564, KME21A3116, KME21B0550, KME21B1155, KME21B1255, KME21B1818, KME21B1901, KME21B2169, KME21B2546, KME21B2858, KME21C0065, KME21C0181, KME21C0183, KME21C0185, KME21C2824, KME21D0137, KME21D0185, KME21D0322, KME21D0644, KME21D0712 |
In light of the foregoing, all concerned healthcare professionals, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batch of Rüsch Endotracheal Tube.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lots/batches stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.