Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565

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 4026704547609, Batch Numbers: 18FG05, 18FG13, 18FG25, 18GG20, 18HG07, 18HG12, 18HG19, 18HG32, 18HG38, 18IG06, 18IG09, 18IG15, 18JG04, 18JG21, 18JG34, 18KG35, 18LG39, 19AG01, 19AG24, 19AG27, 19AG37, 19CT32, 19CT41, 19CT58, 19CT65, 19DT06, 19DT20, 19DT33, 19ET32, 19ET54, 19ET60, 19FT24, 19FT41, 19GT28, 19GT38, 19HT10, 19HT66, 19IT14, 19IT25, 19JT18, 19JT29, 19JT42, 19JT57, 19KT08, 19KT41, 19KT55, 19LT32, 20AT09, 20AT14, 20AT25, 20AT53, 20BT27, 20CT05, 20CT12, 20CT36, 20CT44, 20DT09, 20ET04, 20ET16, 20GT14, KME20G0189, KME20G0316, KME20H2312, KME20H2585, KME20H2586, KME20H2587, KME20J0320, KME20J0570, KME20K0465, KME20K0939, KME20K1551, KME20K1628, KME20K2246, KME20L0488, KME20L1840, KME20M0022, KME20M0854, KME20M1102, KME20M1579, KME21K1128, KME21L0328, KME21L2340, KME21M2283, KME21M2446, KME21M2568, KME22A0675, KME22A2415, KME22A3028, KME22A3156, KME22A3313, KME22B0067, KME22B1218, KME22B1409, KME22C0499, KME22C0863, KME22C1073, KME22C1225, KME22C1655, KME22C1941, KME22D0747, KME22D0755, KME22F1616, KME22F1617, KME22G0632, KME22G1224, KME22G2467, KME22H1900, KME22H3348, KME22J1135, KME22J1136, KME22J1928, KME22J3352, KME22K2413, KME22K2414, KME22L0241, KME22L0242, KME22L1792
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 504565

Product Codes/Lot Numbers:

UDI/DI 4026704547609, Batch Numbers: 18FG05, 18FG13, 18FG25, 18GG20, 18HG07, 18HG12, 18HG19, 18HG32, 18HG38, 18IG06, 18IG09, 18IG15, 18JG04, 18JG21, 18JG34, 18KG35, 18LG39, 19AG01, 19AG24, 19AG27, 19AG37, 19CT32, 19CT41, 19CT58, 19CT65, 19DT06, 19DT20, 19DT33, 19ET32, 19ET54, 19ET60, 19FT24, 19FT41, 19GT28, 19GT38, 19HT10, 19HT66, 19IT14, 19IT25, 19JT18, 19JT29, 19JT42, 19JT57, 19KT08, 19KT41, 19KT55, 19LT32, 20AT09, 20AT14, 20AT25, 20AT53, 20BT27, 20CT05, 20CT12, 20CT36, 20CT44, 20DT09, 20ET04, 20ET16, 20GT14, KME20G0189, KME20G0316, KME20H2312, KME20H2585, KME20H2586, KME20H2587, KME20J0320, KME20J0570, KME20K0465, KME20K0939, KME20K1551, KME20K1628, KME20K2246, KME20L0488, KME20L1840, KME20M0022, KME20M0854, KME20M1102, KME20M1579, KME21K1128, KME21L0328, KME21L2340, KME21M2283, KME21M2446, KME21M2568, KME22A0675, KME22A2415, KME22A3028, KME22A3156, KME22A3313, KME22B0067, KME22B1218, KME22B1409, KME22C0499, KME22C0863, KME22C1073, KME22C1225, KME22C1655, KME22C1941, KME22D0747, KME22D0755, KME22F1616, KME22F1617, KME22G0632, KME22G1224, KME22G2467, KME22H1900, KME22H3348, KME22J1135, KME22J1136, KME22J1928, KME22J3352, KME22K2413, KME22K2414, KME22L0241, KME22L0242, KME22L1792