FDAClass IIAugust 25, 2021

RUSCH Endotracheal Tube oral/nasal Murphy Eye recall

RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e)…

Why was RUSCH Endotracheal Tube oral/nasal Murphy Eye recalled?

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) 112082050, Lot Numbers: KME20K0211, KME20K0463, KME21A2017, KME21A2343, KME21A2686, KME21B2491 b) 112082055, Lot Numbers: KME20K0464, KME20K0683, KME20L1703, KME20M0996, KME21A0492, KME21A1433, KME21C0502, KME21C1347, KME21C1496, KME21C2745, KME21D0835 c) 112082060, Lot Numbers: 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 d) 112082065, Lot Numbers: KME20K0036, KME20K0259, KME20K0436, KME20K0504, 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 e) 112082070, Lot Numbers: 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 f) 112082075, Lot Numbers: 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 g) 112082080, Lot Numbers: 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 h) 112082085, Lot Numbers: 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 i) 112082090, Lot Numbers: KME20K0180, KME20K0212, KME20K0600, KME20K0978, KME20K1434, KME20K3021, KME20K3525, KME20L0805, KME20L1142, KME21A2016, KME21A2676, KME21A3263, KME21B0632, KME21B1283 j) 112082095, Lot Numbers: KME20K1583, KME20K1831, KME20K2166, KME20K2574, KME20L1041, KME20L1592, KME20L2462, KME20L2557, KME20M2115, KME20M2198, KME21A2346, KME21A3264, KME21B1895, KME21C3326 k) 112082100, Lot Numbers: KME20K0977, KME20K1809, KME20K2553, KME20L0335, KME20M1341, KME20M2113, KME21A2342, KME21A2668, KME21C0017, KME21C0068, KME21D0827, KME21D1219

Product
RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e)…
Recalling firm
Teleflex Medical Europe Ltd
Quantity
638220 units
Distribution
US Nationwide distribution.
Recall date
August 25, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls