RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
This recall is currently active, issued July 16, 2021. It was issued by Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland.
- Recall Initiated
- July 16, 2021
- Recall Number
- Z-2320-2021
- Quantity
- 155030 units
- Official Source
- View on FDA website ↗
Reason for Recall
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Distribution
US Nationwide distribution.
Lot / Code Info
a) 504550, Lot Numbers: KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21A2076, KME21A2787, KME21B1140, KME21C0059, KME21C2363 b) 504555, Lot Numbers: KME20K0765, KME20K0766, KME20K0935, KME20K1582, KME20L0619, KME20L1857, KME20L2028, KME20M0020, KME21A1902, KME21A2796, KME21B2681, KME21C2707 c) 504560, Lot Numbers: KME20K1550, KME20L0336, KME20L2298, KME20M0021, KME20M0492, KME21A0380, KME21A0817, KME21A1160, KME21A1770, KME21B1137, KME21B1138, KME21B1139, KME21C3255 d) 504565, Lot Numbers: 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 e) 504570, Lot Numbers: 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 f) 504575, Lot Numbers: 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 g) 504580, Lot Numbers: 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 f) 504585, Lot Numbers: KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21A0891, KME21A1043, KME21A2802, KME21A2803, KME21B0933, KME21B1250, KME21B1251, KME21B2029, KME21C0506, KME21C2107, KME21C2339, KME21C2341, KME21C2553, KME21D0210 g) 504590, Lot Numbers: KME20L0626, KME20M0856, KME20M2091, KME21C0299, KME21C2104, KME21C2105
Root Cause
Process control
Action Taken
The firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers.