The Recall Desk
SevereFDA (Devices)·Z-1858-2023·Announced 2023-07-05

Flexi-Set Endotracheal Tubes recalled due to connector disconnection risk

Teleflex is recalling 12,400 Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets nationwide due to reports of 15mm connector disconnection. The affected batches and lot numbers are identified above.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which is the agency's highest classification level for medical device defects. Per the severity rubric, FDA Class I recalls never score below 4. No illnesses, injuries, or deaths have been reported in the available source material.

Plain-English summary

Teleflex LLC is recalling 12,400 units of the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (REF 506545) nationwide, including Puerto Rico. The U.S. Food and Drug Administration (FDA) classified this as a Class I recall.

The endotracheal tubes in the affected batches have been linked to disconnection of the 15mm connector from the tube. This connector is critical for maintaining the integrity of the airway management system during medical procedures.

The following batch numbers are affected: 18FG05, 18FG13, 18GG20, 18HG16, 18IG06, 18IG12, 18JG04, 18JG14, 18JG21, 18JG34, 18KG35, 18LG02, 18LG18, 18LG28, 19BG21, 19CT49, 19FT35, 19GT20, 19GT28, 19GT38, 19GT59, 19GT65, 19HT24, 19HT80, 19IT29, 19KT25, 19KT48, 19LT38, 20AT09, 20BG16, 20BT05, 20CT05, 20CT36, 20CT44, 20DT37, 20GG45, KME20H2927, KME20H2928, KME20K2248, KME20L0620, KME20L1471, KME20L1472, KME20L2030, KME20M2482, KME21A1892, KME21A1893, KME21A2811, KME21B0576, KME22G3102, KME22J2956, KME22K2778, KME22L3057, KME23A2083, KME23B1203. The UDI/DI number is 4026704547708.

Healthcare facilities and users of this product should immediately check their inventory against the provided batch numbers. Any units matching the affected batches should be quarantined and not used until further guidance is provided.

The recalled product

Product
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway management
Hazard
  • connector-disconnection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI/DI 4026704547708
  • Batch Numbers: 18FG05
  • 18FG13
  • 18GG20
  • 18HG16
  • 18IG06
  • 18IG12
  • 18JG04
  • 18JG14
  • 18JG21
  • 18JG34
  • 18KG35
  • 18LG02
  • 18LG18
  • 18LG28
  • 19BG21
  • 19CT49
  • 19FT35
  • 19GT20
  • 19GT28

Distribution

Distributed nationwide across the United States.

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