🔍 RecallPedia

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550

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 4026704547715, Batch Numbers: 18FG01, 18FG05, 18FG13, 18GG17, 18GG31, 18HG12, 18HG19, 18JG21, 18JG32, 18KG41, 18LG18, 18LG28, 19AG21, 19DT25, 19DT33, 19ET54, 19ET77, 19FT24, 19GT59, 19GT65, 19HT24, 19HT61, 19IT29, 19JT42, 19JT49, 19JT57, 19KT25, 20AT14, 20AT25, 20AT44, 20BT05, 20BT27, 20BT37, 20BT51, 20CT05, 20CT12, 20CT36, 20DT09, 20ET56, 20GT06, 20GT38, KME20H1790, KME20J2114, KME20J3032, KME20K1344, KME20L1842, KME20L1843, KME20L2299, KME20M2094, KME20M2483, KME21A2812, KME21B1693, KME21C0020, KME22B1976, KME22H3204
  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 506550

Product Codes/Lot Numbers:

UDI/DI 4026704547715, Batch Numbers: 18FG01, 18FG05, 18FG13, 18GG17, 18GG31, 18HG12, 18HG19, 18JG21, 18JG32, 18KG41, 18LG18, 18LG28, 19AG21, 19DT25, 19DT33, 19ET54, 19ET77, 19FT24, 19GT59, 19GT65, 19HT24, 19HT61, 19IT29, 19JT42, 19JT49, 19JT57, 19KT25, 20AT14, 20AT25, 20AT44, 20BT05, 20BT27, 20BT37, 20BT51, 20CT05, 20CT12, 20CT36, 20DT09, 20ET56, 20GT06, 20GT38, KME20H1790, KME20J2114, KME20J3032, KME20K1344, KME20L1842, KME20L1843, KME20L2299, KME20M2094, KME20M2483, KME21A2812, KME21B1693, KME21C0020, KME22B1976, KME22H3204

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1859-2023

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