Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580

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 4026704547630, Batch Numbers: 18FG03, 18FG05, 18FG13, 18GG14, 18HG22, 18HG38, 18IG09, 18JG06, 18JG14, 18JG26, 18KG09, 18KG15, 18KG23, 18LG05, 18LG12, 18LG18, 19AG05, 19AG31, 19BG01, 19BG07, 19CT32, 19CT41, 19CT55, 19DT38, 19DT45, 19DT52, 19ET05, 19ET32, 19ET60, 19ET72, 19ET77, 19FT24, 19GT10, 19GT20, 19GT38, 19GT59, 19HT05, 19IT06, 19JT42, 19JT49, 19KT17, 19LT04, 19LT17, 20AT09, 20AT14, 20AT25, 20AT32, 20AT37, 20AT46, 20AT53, 20BT05, 20BT23, 20BT47, 20CT05, 20CT12, 20CT27, 20CT36, 20CT44, 20DT14, 20DT37, 20ET16, 20ET21, 20GT06, 20GT25, KME20H0590, KME20H0973, KME20H0974, KME20H1289, KME20H1290, KME20H2924, KME20H2926, KME20K0449, KME20K0450, KME20K1414, KME20K2622, KME20L1277, KME20L1479, KME20L2302, KME20L2828, KME20M1752, KME20M1753, KME21A0381, KME21A0820, KME21A0823, KME21D1784, KME21E1286, KME21F1330, KME21J0409, KME21K2402, KME21L0372, KME21L1534, KME21L1899, KME21L2812, KME21M2036, KME21M2053, KME21M2870, KME22A0395, KME22A1237, KME22A3025, KME22A3271, KME22A3272, KME22A3283, KME22A3284, KME22A3285, KME22B1406, KME22B1996, KME22B2164, KME22B2329, KME22B2330, KME22B2496, KME22B2504, KME22B2595, KME22C0247, KME22C0865, KME22C1074, KME22C1321, KME22C1322, KME22H3393, KME22J1538, KME22J1713, KME22J3328, KME22K0537, KME22K0602, KME22K0744, KME22K0760, KME22L1503, KME22L1515, KME22M2049
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 504580

Product Codes/Lot Numbers:

UDI/DI 4026704547630, Batch Numbers: 18FG03, 18FG05, 18FG13, 18GG14, 18HG22, 18HG38, 18IG09, 18JG06, 18JG14, 18JG26, 18KG09, 18KG15, 18KG23, 18LG05, 18LG12, 18LG18, 19AG05, 19AG31, 19BG01, 19BG07, 19CT32, 19CT41, 19CT55, 19DT38, 19DT45, 19DT52, 19ET05, 19ET32, 19ET60, 19ET72, 19ET77, 19FT24, 19GT10, 19GT20, 19GT38, 19GT59, 19HT05, 19IT06, 19JT42, 19JT49, 19KT17, 19LT04, 19LT17, 20AT09, 20AT14, 20AT25, 20AT32, 20AT37, 20AT46, 20AT53, 20BT05, 20BT23, 20BT47, 20CT05, 20CT12, 20CT27, 20CT36, 20CT44, 20DT14, 20DT37, 20ET16, 20ET21, 20GT06, 20GT25, KME20H0590, KME20H0973, KME20H0974, KME20H1289, KME20H1290, KME20H2924, KME20H2926, KME20K0449, KME20K0450, KME20K1414, KME20K2622, KME20L1277, KME20L1479, KME20L2302, KME20L2828, KME20M1752, KME20M1753, KME21A0381, KME21A0820, KME21A0823, KME21D1784, KME21E1286, KME21F1330, KME21J0409, KME21K2402, KME21L0372, KME21L1534, KME21L1899, KME21L2812, KME21M2036, KME21M2053, KME21M2870, KME22A0395, KME22A1237, KME22A3025, KME22A3271, KME22A3272, KME22A3283, KME22A3284, KME22A3285, KME22B1406, KME22B1996, KME22B2164, KME22B2329, KME22B2330, KME22B2496, KME22B2504, KME22B2595, KME22C0247, KME22C0865, KME22C1074, KME22C1321, KME22C1322, KME22H3393, KME22J1538, KME22J1713, KME22J3328, KME22K0537, KME22K0602, KME22K0744, KME22K0760, KME22L1503, KME22L1515, KME22M2049