🔍 RecallPedia

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555

Class I - Dangerous
🏥 Medical Devices Recalled: May 25, 2023 TELEFLEX Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 4026704547586, Batch Numbers: 18FG20, 18FG22, 18FG25, 18FT32, 18GG14, 18HG12, 18HG27, 18IG06, 18IG24, 18IG27, 18JG02, 18JG14, 18KG07, 18KG23, 18KG35, 18LG31, 19AG27, 19BG04, 19CT55, 19ET72, 19FT30, 19GT05, 19GT10, 19GT20, 19GT38, 19GT59, 19GT65, 19HT61, 19IT25, 19JT29, 19JT42, 19JT49, 19KT30, 19KT41, 19LT04, 19LT50, 20AT09, 20AT44, 20BT05, 20BT13, 20BT27, 20BT37, 20CT05, 20CT12, 20CT36, 20ET21, KME20G0388, KME20J0319, KME20J2321, KME21H1189, KME22A0148, KME22A2939, KME22A2940, KME22A3267, KME22A3268, KME22B1633, KME22B1751, KME22C3207, KME22D0590, KME22D1785, KME22E0619, KME22E0620, KME22F1666, KME22G0225, KME22G2294, KME22H3105, KME22J1458, KME22J1459, KME22J2714, KME22L1104, KME22L1105, KME23C0590
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 504555

Product Codes/Lot Numbers:

UDI/DI 4026704547586, Batch Numbers: 18FG20, 18FG22, 18FG25, 18FT32, 18GG14, 18HG12, 18HG27, 18IG06, 18IG24, 18IG27, 18JG02, 18JG14, 18KG07, 18KG23, 18KG35, 18LG31, 19AG27, 19BG04, 19CT55, 19ET72, 19FT30, 19GT05, 19GT10, 19GT20, 19GT38, 19GT59, 19GT65, 19HT61, 19IT25, 19JT29, 19JT42, 19JT49, 19KT30, 19KT41, 19LT04, 19LT50, 20AT09, 20AT44, 20BT05, 20BT13, 20BT27, 20BT37, 20CT05, 20CT12, 20CT36, 20ET21, KME20G0388, KME20J0319, KME20J2321, KME21H1189, KME22A0148, KME22A2939, KME22A2940, KME22A3267, KME22A3268, KME22B1633, KME22B1751, KME22C3207, KME22D0590, KME22D1785, KME22E0619, KME22E0620, KME22F1666, KME22G0225, KME22G2294, KME22H3105, KME22J1458, KME22J1459, KME22J2714, KME22L1104, KME22L1105, KME23C0590

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1846-2023

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