Z-1889-2023 Class I Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

FDA device recall Z-1889-2023 was initiated by TELEFLEX LLC on May 25, 2023 and is designated Class I. Reason for recall: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. The recall status is ongoing. Affected quantity: 300613 units.

Recall Details

Product Type
Devices
Report Date
Jul 5, 2023
Initiation Date
May 25, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300613 units

Product Description

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075

Reason for Recall

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Distribution Pattern

US Nationwide distribution including Puerto Rico.

Code Information

UDI/DI 14026704341433, Batch Numbers: 18FG29, 18GG13, 18GG15, 18GG26, 18GT32, 18GT34, 18HG14, 18HG21, 18HG23, 18HG24, 18HG27, 18HT15, 18HT31, 18IG25, 18IG29, 18IT04, 18IT23, 18IT25, 18JG10, 18JT22, 18KG05, 18KT11, 18LG19, 18LG38, 18LG40, 18LT07, 19AG21, 19BG01, 19BG04, 19BG06, 19BG37, 19BT04, 19BT12, 19BT18, 19CG04, 19CG06, 19CT03, 19CT04, 19CT20, 19CT26, 19CT34, 19CT42, 19CT50, 19CT57, 19CT64, 19CT69, 19DT10, 19DT34, 19DT36, 19DT42, 19ET02, 19ET06, 19ET08, 19ET22, 19ET29, 19ET34, 19ET36, 19ET70, 19ET72, 19ET82, 19FT04, 19FT25, 19FT33, 19GT02, 19GT14, 19GT16, 19GT25, 19GT29, 19GT64, 19HT03, 19HT09, 19HT15, 19HT71, 19IT12, 19IT13, 19IT41, 19IT42, 19IT45, 19JT11, 19JT14, 19KT26, 19KT35, 19KT48, 19KT49, 19LT07, 19LT23, 19LT31, 19LT35, 19LT54, 20AT11, 20AT20, 20AT22, 20AT26, 20AT47, 20AT58, 20BT01, 20BT25, 20BT31, 20BT39, 20BT50, 20BT51, 20CT42, 20CT43, 20CT51, 20CT53, 20CT54, 20DT01, 20DT32, 20DT37, 20ET12, 20FT35, 20FT36, 20FT39, 20FT43, 20FT49, 20FT53, 20FT55, 20FT71, 20GG41, 20GG42, 20GT10, 20GT11, 20GT14, 20GT25, 20GT41, 20GT51, 20GT57, KME20J2944, KME20J2988, KME20K1113, KME20L1298, KME20L1299, KME20L1704, KME20L1924, KME20L1983, KME20L2605, KME20L2798, KME20M0034, KME20M0321, KME20M1067, KME20M1507, KME21A3004, KME21A3259, KME21B0179, KME21B0823, KME21B2480, KME21C0615, KME21C0661, KME21C0730, KME21C0826, KME21C0855, KME21C2026, KME21D1923, KME21D1956, KME21D2014, KME21D2018, KME21D2262, KME21E0021, KME21E0288, KME21E0469, KME21E0498, KME21E1186, KME21E1264, KME21F0385, KME21F0557, KME21F0725, KME21F1583, KME21F1607, KME21F1696, KME21F1751, KME21F2182, KME21G0114, KME21G0169, KME21G1942, KME21H0829, KME21J0200, KME21J0359, KME21J0418, KME21J0671, KME21J0763, KME21J1212, KME21J1709, KME21J1842, KME21K0305, KME21K0986, KME21K1712, KME21K1855, KME21K2531, KME21K2745, KME21L0628, KME21L0880, KME21L1025, KME21L1443, KME21L1581, KME21L1663, KME21L1698, KME21L1992, KME21L2222, KME21L2455, KME21L2775, KME21M0193, KME21M0314, KME21M0500, KME21M0690, KME21M0802, KME21M0852, KME21M1006, KME21M1065, KME21M1085, KME21M1245, KME21M1268, KME21M1583, KME21M1613, KME21M1749, KME21M2745, KME21M2871, KME22A0545, KME22A0854, KME22A0940, KME22A1136, KME22A1224, KME22A1367, KME22A1392, KME22A1990, KME22A2129, KME22A2315, KME22A2414, KME22A2537, KME22A2602, KME22A2603, KME22A2898, KME22A2937, KME22A3082, KME22A3219, KME22A3222, KME22A3238, KME22B0266, KME22C2126, KME22C2350, KME22C2437, KME22C2439, KME22C2756, KME22C2855, KME22C3145, KME22D0324, KME22D0464, KME22D1176, KME22D1481, KME22D1660, KME22D1688, KME22D2635, KME22D2853, KME22D3116, KME22D3236, KME22D3419, KME22D3420, KME22D3711, KME22E0179, KME22E0319, KME22E0321, KME22E0322, KME22E0641, KME22E0642, KME22E2647, KME22E3002, KME22F0185, KME22F0317, KME22F0775, KME22F1265, KME22F2028, KME22F2237, KME22F2721, KME22J1258, KME22J3143, KME22J3344

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1889-2023
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.