Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550

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 4026704547579, Batch Numbers: 18FG03, 18FG13, 18GG12, 18GG17, 18GG31, 18HG12, 18IG02, 18IG12, 18IG21, 18IG27, 18JG02, 18KG15, 18LG25, 18LG37, 19AG37, 19BG07, 19BG21, 19CT71, 19ET54, 19FT14, 19FT24, 19GT10, 19GT20, 19GT38, 19GT65, 19HT05, 19HT40, 19HT66, 19JT70, 19KT08, 19LT17, 19LT32, 20AT14, 20AT25, 20BT27, 20BT37, 20CT36, 20CT54, 20DT14, 20ET04, 20ET21, 20GT38, KME20H0128, KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21D1964, KME21F1551, KME21G1707, KME21K0545, KME21K1249, KME21M0011, KME21M1831, KME21M2074, KME21M2647, KME22B0171, KME22B0172, KME22B1395, KME22B1632, KME22C0436, KME22C1654, KME22C3003, KME22D0145, KME22D0825, KME22E1129, KME22H0163, KME22H1169, KME22H1703, KME22H1709, KME22J3162, KME22J3163
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 504550

Product Codes/Lot Numbers:

UDI/DI 4026704547579, Batch Numbers: 18FG03, 18FG13, 18GG12, 18GG17, 18GG31, 18HG12, 18IG02, 18IG12, 18IG21, 18IG27, 18JG02, 18KG15, 18LG25, 18LG37, 19AG37, 19BG07, 19BG21, 19CT71, 19ET54, 19FT14, 19FT24, 19GT10, 19GT20, 19GT38, 19GT65, 19HT05, 19HT40, 19HT66, 19JT70, 19KT08, 19LT17, 19LT32, 20AT14, 20AT25, 20BT27, 20BT37, 20CT36, 20CT54, 20DT14, 20ET04, 20ET21, 20GT38, KME20H0128, KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21D1964, KME21F1551, KME21G1707, KME21K0545, KME21K1249, KME21M0011, KME21M1831, KME21M2074, KME21M2647, KME22B0171, KME22B0172, KME22B1395, KME22B1632, KME22C0436, KME22C1654, KME22C3003, KME22D0145, KME22D0825, KME22E1129, KME22H0163, KME22H1169, KME22H1703, KME22H1709, KME22J3162, KME22J3163