Recalls / —

—#200830

Product

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

FDA product code

BTR — Tube, Tracheal (W/Wo Connector)

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K961837

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/25/2012 by FedEx. The notice explained the problem, the risk, and requested the following: Users should cease use and distribution of affected product and immediately quarantine the affected product. Distributors were directed to cease use, distribution, and quarantine the product, and to notify their customers. Teleflex is seeking the return of the affected product. For further information: Contact: Customer Service, Telephone: 1-866-396-2111 FAX: 1-855-419-8507, Email: Recalls@teleflex.com

Recalling firm

Firm

TELEFLEX LLC

Address

3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern

US Nationwide distribution including Puerto Rico.

Timeline

Recall initiated

2023-05-25

Posted by FDA

2023-06-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #200830. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.