Flexi-Set Cuffed Endotracheal Tube and Stylet Set recall
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575
Why was Flexi-Set Cuffed Endotracheal Tube and Stylet Set recalled?
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575
- Recalling firm
- TELEFLEX LLC
- Quantity
- 684042 units
- Distribution
- US Nationwide distribution including Puerto Rico.
- Recall date
- July 5, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)