Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590

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 4026704547654, Batch Numbers: 18FG18, 18FG20, 18GG17, 18GT32, 18HG12, 18HG27, 18HG38, 18IG15, 18IG30, 18KG03, 18KG07, 18KG35, 18LG18, 19AG24, 19AG27, 19BG04, 19DT38, 19DT45, 19ET32, 19ET72, 19FT14, 19GT20, 19HT40, 19IT39, 19IT58, 19KT17, 19KT21, 19LT50, 20BG16, 20BT05, 20BT47, 20CT36, 20CT44, KME20H0238, KME20H0239, KME20H0591, KME20J2420, KME21E1114, KME22B1404, KME22B1405, KME22B1755, KME22C0915, KME22C1943, KME22C2372, KME22D1717, KME22D1718, KME22G1443, KME23A2760, KME23C0137
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 504590

Product Codes/Lot Numbers:

UDI/DI 4026704547654, Batch Numbers: 18FG18, 18FG20, 18GG17, 18GT32, 18HG12, 18HG27, 18HG38, 18IG15, 18IG30, 18KG03, 18KG07, 18KG35, 18LG18, 19AG24, 19AG27, 19BG04, 19DT38, 19DT45, 19ET32, 19ET72, 19FT14, 19GT20, 19HT40, 19IT39, 19IT58, 19KT17, 19KT21, 19LT50, 20BG16, 20BT05, 20BT47, 20CT36, 20CT44, KME20H0238, KME20H0239, KME20H0591, KME20J2420, KME21E1114, KME22B1404, KME22B1405, KME22B1755, KME22C0915, KME22C1943, KME22C2372, KME22D1717, KME22D1718, KME22G1443, KME23A2760, KME23C0137