The Recall Desk
SevereFDA (Devices)·Z-1846-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Risk in Flexi-Set Kit

Flexi-Set Cuffed Endotracheal Tube kits are being recalled due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed nationwide.

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: FDA classified this as a Class I recall, which mandates a minimum severity of Severe per the rubric. While no deaths or injuries are reported in the source text, connector disconnection in critical airway management equipment represents a serious potential safety hazard.

Plain-English summary

Teleflex LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets (REF 504555) due to reports of disconnection of the 15mm connector from the endotracheal tube.

The affected products include 42,214 units distributed nationwide in the United States and Puerto Rico. Multiple batch numbers are affected, spanning production from 2018 to 2023.

Healthcare facilities using these products should immediately cease use of affected units and consult the FDA recall notice for batch identification and proper procedures. Affected products are identified by UDI/DI number 4026704547586.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
42,214

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 4026704547586
  • Batch Numbers: 18FG20
  • 18FG22
  • 18FG25
  • 18FT32
  • 18GG14
  • 18HG12
  • 18HG27
  • 18IG06
  • 18IG24
  • 18IG27
  • 18JG02
  • 18JG14
  • 18KG07
  • 18KG23
  • 18KG35
  • 18LG31
  • 19AG27
  • 19BG04
  • 19CT55

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 123 recalled by TELEFLEX LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 123 products in this recall →

Related recalls

Same manufacturer · TELEFLEX LLC

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Same hazard · connector disconnection

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