Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585

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 4026704547647, Batch Numbers: 18FG13, 18FG15, 18FG25, 18GG20, 18GG28, 18HG12, 18HG19, 18IG06, 18IG27, 18JG02, 18JG23, 18JG26, 18KG18, 18KG23, 19AG05, 19AG31, 19AG37, 19CT17, 19CT58, 19CT71, 19DT02, 19ET32, 19ET45, 19FT14, 19FT24, 19GT52, 19HT61, 19HT80, 19IT39, 19KT17, 19KT48, 19LT50, 20AT32, 20AT53, 20BT05, 20CT12, 20CT44, 20DT09, 20DT37, 20GG27, 20GG45, 20GT38, KME20H0532, KME20J2404, KME20J2405, KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21E1295, KME21K1874, KME21M1728, KME21M2447, KME21M2519, KME22B0987, KME22B1754, KME22B2155, KME22C0679, KME22C0866, KME22C2001, KME22C2381, KME22D0823, KME22F1553, KME22F2230, KME22H0145, KME22J0252, KME22J0259, KME22J0470, KME22J2352, KME22L2186, KME22L2295, KME22L2804
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 504585

Product Codes/Lot Numbers:

UDI/DI 4026704547647, Batch Numbers: 18FG13, 18FG15, 18FG25, 18GG20, 18GG28, 18HG12, 18HG19, 18IG06, 18IG27, 18JG02, 18JG23, 18JG26, 18KG18, 18KG23, 19AG05, 19AG31, 19AG37, 19CT17, 19CT58, 19CT71, 19DT02, 19ET32, 19ET45, 19FT14, 19FT24, 19GT52, 19HT61, 19HT80, 19IT39, 19KT17, 19KT48, 19LT50, 20AT32, 20AT53, 20BT05, 20CT12, 20CT44, 20DT09, 20DT37, 20GG27, 20GG45, 20GT38, KME20H0532, KME20J2404, KME20J2405, KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21E1295, KME21K1874, KME21M1728, KME21M2447, KME21M2519, KME22B0987, KME22B1754, KME22B2155, KME22C0679, KME22C0866, KME22C2001, KME22C2381, KME22D0823, KME22F1553, KME22F2230, KME22H0145, KME22J0252, KME22J0259, KME22J0470, KME22J2352, KME22L2186, KME22L2295, KME22L2804