Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525

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 4026704547661, Batch Numbers: 18FG05, 18FG13, 18GG17, 18GG28, 18HG16, 18HG25, 18HG29, 18HG35, 18HG38, 18IG06, 18IG12, 18IG24, 18IG27, 18JG11, 18JG14, 18JG26, 18JG34, 18KG23, 18LG05, 18LG12, 18LG22, 19AG18, 19AG21, 19AG37, 19CT32, 19CT55, 19ET45, 19GT05, 19GT20, 19GT38, 19GT59, 19HT05, 19HT15, 19HT40, 19HT80, 19IT29, 19KT08, 19KT25, 19KT41, 19KT48, 19LT04, 20AT25, 20AT46, 20BT13, 20BT27, 20CT12, 20CT22, 20CT36, 20CT51, 20DT37, 20ET16, 20ET28, 20FT44, KME20L0615, KME20M2047, KME21A1889, KME21A1890, KME21A2804, KME21B1143, KME21B1672, KME21C0063, KME21C0301, KME21M1833, KME22B0302, KME22B1071, KME22C3357, KME22D0784, KME22D1062, KME22D3648, KME22E1130, KME22F0161, KME22F1501, KME22G0561, KME22G1100, KME22H2626, KME22K0013, KME22K0331, KME22K2365, KME22L0760
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 506525

Product Codes/Lot Numbers:

UDI/DI 4026704547661, Batch Numbers: 18FG05, 18FG13, 18GG17, 18GG28, 18HG16, 18HG25, 18HG29, 18HG35, 18HG38, 18IG06, 18IG12, 18IG24, 18IG27, 18JG11, 18JG14, 18JG26, 18JG34, 18KG23, 18LG05, 18LG12, 18LG22, 19AG18, 19AG21, 19AG37, 19CT32, 19CT55, 19ET45, 19GT05, 19GT20, 19GT38, 19GT59, 19HT05, 19HT15, 19HT40, 19HT80, 19IT29, 19KT08, 19KT25, 19KT41, 19KT48, 19LT04, 20AT25, 20AT46, 20BT13, 20BT27, 20CT12, 20CT22, 20CT36, 20CT51, 20DT37, 20ET16, 20ET28, 20FT44, KME20L0615, KME20M2047, KME21A1889, KME21A1890, KME21A2804, KME21B1143, KME21B1672, KME21C0063, KME21C0301, KME21M1833, KME22B0302, KME22B1071, KME22C3357, KME22D0784, KME22D1062, KME22D3648, KME22E1130, KME22F0161, KME22F1501, KME22G0561, KME22G1100, KME22H2626, KME22K0013, KME22K0331, KME22K2365, KME22L0760