Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575

Class I - Dangerous

🏥 Medical Devices Recalled: May 25, 2023 TELEFLEX Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
UDI/DI 4026704547623, Batch Numbers: 18FG05, 18FG13, 18FG30, 18GG02, 18GG08, 18GG12, 18GG17, 18GG20, 18GG28, 18HG01, 18HG12, 18HG22, 18HG27, 18HG35, 18HG38, 18IG09, 18IG17, 18IG27, 18IG30, 18JG14, 18JG17, 18KG07, 18KG09, 18KG18, 18KG29, 18KG41, 18KG44, 18LG02, 18LG05, 18LG12, 18LG22, 18LG31, 19AG05, 19AG18, 19AG24, 19AG27, 19AG31, 19AG34, 19BG01, 19BG07, 19CT20, 19CT32, 19CT37, 19CT49, 19CT55, 19CT58, 19CT65, 19DT38, 19DT45, 19ET05, 19ET22, 19ET28, 19ET45, 19ET50, 19ET54, 19ET60, 19FT01, 19FT14, 19FT24, 19FT35, 19FT41, 19FT49, 19GT01, 19GT05, 19GT10, 19GT28, 19GT38, 19GT59, 19HT05, 19HT10, 19HT61, 19HT70, 19HT75, 19HT80, 19IT06, 19IT14, 19IT25, 19IT29, 19IT39, 19IT44, 19JT22, 19JT57, 19JT70, 19KT08, 19KT25, 19KT48, 19LT04, 19LT10, 19LT23, 19LT50, 20AT09, 20AT14, 20AT25, 20AT32, 20AT37, 20AT46, 20AT53, 20CT05, 20CT12, 20CT27, 20CT36, 20CT44, 20DT09, 20DT37, 20ET04, 20ET16, 20ET37, 20ET56, 20FT61, 20FT65, 20GT06, 20GT31, 20GT38, 20GT49, KME20H0980, KME20H0981, KME20H1654, KME20H1794, KME20H1848, KME20J0061, KME20J0157, KME20J0322, KME20J0323, KME20J0576, KME20J0829, KME20J0831, KME20J0834, KME20J1114, KME20J2544, 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, KME21A2799, KME21A2815, KME21G1164, KME21G1165, KME21G1356, KME21G2407, KME21J0947, KME21J1716, KME21J1841, KME21K0659, KME21K1347, KME21K1765, KME21K1844, KME21K2349, KME21K2974, KME21L0634, KME21L0876, KME21L1024, KME21L1392, KME21L2221, KME21L2348, KME21L2765, KME21M0086, KME21M0286, KME21M0363, KME21M0546, KME21M0962, KME21M1889, KME21M2037, KME21M2325, KME21M2564, KME21M2848, KME22A0204, KME22A0546, KME22A1057, KME22A1198, KME22A1514, KME22A1588, KME22A1725, KME22A1727, KME22A1753, KME22A1877, KME22A1912, KME22A2057, KME22A3084, KME22A3086, KME22A3087, KME22A3151, KME22A3270, KME22B0570, KME22B0649, KME22B0850, KME22B1220, KME22B1407, KME22B2126, KME22B2127, KME22B2128, KME22B2162, KME22B2333, KME22B2471, KME22B2472, KME22B2497, KME22B2703, KME22B2903, KME22C0243, KME22C1859, KME22C2294, KME22C2402, KME22C2578, KME22D1474, KME22D2638, KME22D3063, KME22D3064, KME22D3677, KME22G1070, KME22G1071, KME22H2369, KME22H2372, KME22H2630, KME22H2905, KME22J0801, KME22J0802, KME22J2720, KME22J2721, KME22J3353, KME22K0311, KME22K0313
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: TELEFLEX LLC
Reason for Recall:: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575

Product Codes/Lot Numbers:

UDI/DI 4026704547623, Batch Numbers: 18FG05, 18FG13, 18FG30, 18GG02, 18GG08, 18GG12, 18GG17, 18GG20, 18GG28, 18HG01, 18HG12, 18HG22, 18HG27, 18HG35, 18HG38, 18IG09, 18IG17, 18IG27, 18IG30, 18JG14, 18JG17, 18KG07, 18KG09, 18KG18, 18KG29, 18KG41, 18KG44, 18LG02, 18LG05, 18LG12, 18LG22, 18LG31, 19AG05, 19AG18, 19AG24, 19AG27, 19AG31, 19AG34, 19BG01, 19BG07, 19CT20, 19CT32, 19CT37, 19CT49, 19CT55, 19CT58, 19CT65, 19DT38, 19DT45, 19ET05, 19ET22, 19ET28, 19ET45, 19ET50, 19ET54, 19ET60, 19FT01, 19FT14, 19FT24, 19FT35, 19FT41, 19FT49, 19GT01, 19GT05, 19GT10, 19GT28, 19GT38, 19GT59, 19HT05, 19HT10, 19HT61, 19HT70, 19HT75, 19HT80, 19IT06, 19IT14, 19IT25, 19IT29, 19IT39, 19IT44, 19JT22, 19JT57, 19JT70, 19KT08, 19KT25, 19KT48, 19LT04, 19LT10, 19LT23, 19LT50, 20AT09, 20AT14, 20AT25, 20AT32, 20AT37, 20AT46, 20AT53, 20CT05, 20CT12, 20CT27, 20CT36, 20CT44, 20DT09, 20DT37, 20ET04, 20ET16, 20ET37, 20ET56, 20FT61, 20FT65, 20GT06, 20GT31, 20GT38, 20GT49, KME20H0980, KME20H0981, KME20H1654, KME20H1794, KME20H1848, KME20J0061, KME20J0157, KME20J0322, KME20J0323, KME20J0576, KME20J0829, KME20J0831, KME20J0834, KME20J1114, KME20J2544, 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, KME21A2799, KME21A2815, KME21G1164, KME21G1165, KME21G1356, KME21G2407, KME21J0947, KME21J1716, KME21J1841, KME21K0659, KME21K1347, KME21K1765, KME21K1844, KME21K2349, KME21K2974, KME21L0634, KME21L0876, KME21L1024, KME21L1392, KME21L2221, KME21L2348, KME21L2765, KME21M0086, KME21M0286, KME21M0363, KME21M0546, KME21M0962, KME21M1889, KME21M2037, KME21M2325, KME21M2564, KME21M2848, KME22A0204, KME22A0546, KME22A1057, KME22A1198, KME22A1514, KME22A1588, KME22A1725, KME22A1727, KME22A1753, KME22A1877, KME22A1912, KME22A2057, KME22A3084, KME22A3086, KME22A3087, KME22A3151, KME22A3270, KME22B0570, KME22B0649, KME22B0850, KME22B1220, KME22B1407, KME22B2126, KME22B2127, KME22B2128, KME22B2162, KME22B2333, KME22B2471, KME22B2472, KME22B2497, KME22B2703, KME22B2903, KME22C0243, KME22C1859, KME22C2294, KME22C2402, KME22C2578, KME22D1474, KME22D2638, KME22D3063, KME22D3064, KME22D3677, KME22G1070, KME22G1071, KME22H2369, KME22H2372, KME22H2630, KME22H2905, KME22J0801, KME22J0802, KME22J2720, KME22J2721, KME22J3353, KME22K0311, KME22K0313