Home / Recalls / Teleflex Medical Europe Ltd / Z-2320-2021

Z-2320-2021 Class II Terminated

Recalled by Teleflex Medical Europe Ltd — Athlone, N/A

FDA device recall Z-2320-2021 was initiated by Teleflex Medical Europe Ltd on July 16, 2021 and is designated Class II. Reason for recall: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. The recall status is terminated (terminated July 24, 2026). Affected quantity: 155030 units.

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
July 16, 2021
Termination Date
July 24, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
155030 units

Product Description

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

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

Other recalls by Teleflex Medical Europe Ltd

  • Z-2319-2021 Class II — RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers (July 16, 2021)
  • Z-2322-2021 Class II — RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, R (July 16, 2021)
  • Z-2321-2021 Class II — RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF n (July 16, 2021)
  • Z-2287-2018 Class II — Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage (June 12, 2018)
  • Z-1403-2018 Class II — Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, Q (March 27, 2018)
  • Z-1628-2018 Class II — Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, (March 19, 2018)
  • Z-1367-2018 Class II — Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) (March 15, 2018)
  • Z-1370-2018 Class II — Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (March 15, 2018)
  • Z-1368-2018 Class II — Rectal Catheters; Product Code Equivalent Code 580114 580114 Pro (March 15, 2018)
  • Z-1369-2018 Class II — Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Co (March 15, 2018)

FDA data resources