Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560

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 4026704547593, Batch Numbers: 18FG03, 18FG15, 18FG28, 18GG24, 18IG27, 18JG02, 18JG17, 18JG26, 18JG34, 18KG09, 18KG35, 18LG05, 18LG12, 18LG18, 18LG37, 19AG27, 19AG37, 19BG12, 19CT32, 19CT41, 19CT55, 19CT58, 19ET66, 19ET77, 19FT14, 19FT24, 19FT35, 19GT05, 19GT45, 19HT05, 19HT61, 19JT42, 19KT17, 19KT21, 19KT65, 19LT04, 19LT23, 20AT09, 20AT37, 20AT53, 20BT51, 20CT05, 20CT12, 20CT36, 20DT37, 20ET04, 20FT10, 20FT35, 20GT06, KME20H0129, KME20H0906, KME20H1791, KME20H1847, KME20J0848, KME20K1550, KME20L0336, KME20M0492, KME21E1412, KME21G2207, KME21H0839, KME21H0972, KME21H1124, KME21K0660, KME21K1165, KME21L0442, KME21L0443, KME21L1900, KME21L2539, KME21M1391, KME22A1432, KME22B1411, KME22C1068, KME22C2858, KME22D0479, KME22D0482, KME22D0592, KME22D2846
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 504560

Product Codes/Lot Numbers:

UDI/DI 4026704547593, Batch Numbers: 18FG03, 18FG15, 18FG28, 18GG24, 18IG27, 18JG02, 18JG17, 18JG26, 18JG34, 18KG09, 18KG35, 18LG05, 18LG12, 18LG18, 18LG37, 19AG27, 19AG37, 19BG12, 19CT32, 19CT41, 19CT55, 19CT58, 19ET66, 19ET77, 19FT14, 19FT24, 19FT35, 19GT05, 19GT45, 19HT05, 19HT61, 19JT42, 19KT17, 19KT21, 19KT65, 19LT04, 19LT23, 20AT09, 20AT37, 20AT53, 20BT51, 20CT05, 20CT12, 20CT36, 20DT37, 20ET04, 20FT10, 20FT35, 20GT06, KME20H0129, KME20H0906, KME20H1791, KME20H1847, KME20J0848, KME20K1550, KME20L0336, KME20M0492, KME21E1412, KME21G2207, KME21H0839, KME21H0972, KME21H1124, KME21K0660, KME21K1165, KME21L0442, KME21L0443, KME21L1900, KME21L2539, KME21M1391, KME22A1432, KME22B1411, KME22C1068, KME22C2858, KME22D0479, KME22D0482, KME22D0592, KME22D2846