Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535

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 4026704547685, Batch Numbers: 18FG05, 18FG20, 18GG12, 18GG17, 18GG28, 18GT32, 18HG12, 18HG16, 18JG17, 18KG07, 18LG02, 18LG22, 18LG28, 19AG21, 19BG40, 19CT58, 19ET38, 19ET60, 19ET72, 19FT01, 19GT05, 19GT10, 19GT20, 19GT45, 19GT59, 19GT65, 19HT05, 19HT40, 19HT61, 19HT80, 19IT29, 19JT49, 19KT08, 19LT04, 19LT48, 20AT32, 20AT53, 20BT05, 20BT23, 20BT47, 20CT12, 20CT22, 20CT36, 20CT44, 20DT14, 20DT37, 20ET16, 20ET21, 20ET28, 20FT44, KME20K1624, KME20K3589, KME20L0616, KME20L0617, KME20M2049, KME20M3274, KME20M3275, KME20M3278, KME21A1899, KME21A2809, KME21B0575, KME21C0027, KME21C0491, KME22A0057, KME22A0206, KME22B0539, KME22B0725, KME22B1028, KME22B1562, KME22C0916, KME22C1821, KME22C1940, KME22D0350, KME22D1078, KME22F0162, KME22F2162, KME22G3101, KME22G3233, KME22H2624, KME22J0803, KME22J3077
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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506535

Product Codes/Lot Numbers:

UDI/DI 4026704547685, Batch Numbers: 18FG05, 18FG20, 18GG12, 18GG17, 18GG28, 18GT32, 18HG12, 18HG16, 18JG17, 18KG07, 18LG02, 18LG22, 18LG28, 19AG21, 19BG40, 19CT58, 19ET38, 19ET60, 19ET72, 19FT01, 19GT05, 19GT10, 19GT20, 19GT45, 19GT59, 19GT65, 19HT05, 19HT40, 19HT61, 19HT80, 19IT29, 19JT49, 19KT08, 19LT04, 19LT48, 20AT32, 20AT53, 20BT05, 20BT23, 20BT47, 20CT12, 20CT22, 20CT36, 20CT44, 20DT14, 20DT37, 20ET16, 20ET21, 20ET28, 20FT44, KME20K1624, KME20K3589, KME20L0616, KME20L0617, KME20M2049, KME20M3274, KME20M3275, KME20M3278, KME21A1899, KME21A2809, KME21B0575, KME21C0027, KME21C0491, KME22A0057, KME22A0206, KME22B0539, KME22B0725, KME22B1028, KME22B1562, KME22C0916, KME22C1821, KME22C1940, KME22D0350, KME22D1078, KME22F0162, KME22F2162, KME22G3101, KME22G3233, KME22H2624, KME22J0803, KME22J3077