🔍 RecallPedia

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540

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 4026704547692, Batch Numbers: 18FG05, 18FG13, 18FG22, 18GG17, 18GG28, 18GT32, 18HG16, 18JG02, 18JG17, 18JG32, 18JG34, 18KG29, 18KG35, 18LG02, 18LG12, 18LG18, 18LG28, 19AG21, 19BG21, 19BG40, 19ET38, 19ET60, 19ET72, 19FT01, 19FT18, 19FT35, 19GT05, 19GT28, 19HT15, 19HT40, 19HT80, 19IT39, 19JT57, 19LT04, 19LT17, 20AT09, 20AT32, 20AT53, 20BT23, 20CT12, 20CT22, 20CT36, 20ET49, 20ET56, 20GG45, KME20J2322, KME20K0940, KME20K2247, KME20L0621, KME20L1470, KME20L2029, KME20M2093, KME20M2481, KME21A0670, KME21A2814, KME21B1689, KME21B1692, KME22B1078, KME22C1972, KME22C2370, KME22D0541, KME22D0788, KME22E0224, KME22E1238, KME22F0048, KME22G2817
  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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540

Product Codes/Lot Numbers:

UDI/DI 4026704547692, Batch Numbers: 18FG05, 18FG13, 18FG22, 18GG17, 18GG28, 18GT32, 18HG16, 18JG02, 18JG17, 18JG32, 18JG34, 18KG29, 18KG35, 18LG02, 18LG12, 18LG18, 18LG28, 19AG21, 19BG21, 19BG40, 19ET38, 19ET60, 19ET72, 19FT01, 19FT18, 19FT35, 19GT05, 19GT28, 19HT15, 19HT40, 19HT80, 19IT39, 19JT57, 19LT04, 19LT17, 20AT09, 20AT32, 20AT53, 20BT23, 20CT12, 20CT22, 20CT36, 20ET49, 20ET56, 20GG45, KME20J2322, KME20K0940, KME20K2247, KME20L0621, KME20L1470, KME20L2029, KME20M2093, KME20M2481, KME21A0670, KME21A2814, KME21B1689, KME21B1692, KME22B1078, KME22C1972, KME22C2370, KME22D0541, KME22D0788, KME22E0224, KME22E1238, KME22F0048, KME22G2817

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1857-2023

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