The Recall Desk
SevereFDA (Devices)·Z-1851-2023·Announced 2023-07-05

Flexi-Set Endotracheal Tube Connector May Disconnect During Use

Teleflex is recalling 244,120 Flexi-Set Cuffed Endotracheal Tubes due to reports that the 15mm connector may disconnect 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: This FDA Class I recall for a structural connector defect on a critical airway device requires a minimum severity score of 4 per the rubric. No illnesses or injuries are reported in the source material.

Plain-English summary

Teleflex LLC is recalling 244,120 units of the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504580) for oral and nasal use. The recall is due to reports of disconnection of the 15mm connector from the endotracheal tube.

The affected units were distributed nationwide, including Puerto Rico. Batch numbers and product codes for the recall are specified by the FDA.

Healthcare facilities using these tubes should verify their inventory against the FDA recall list. For further information and recommended actions, consult the FDA's official recall notice or contact Teleflex directly.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
Manufacturer
TELEFLEX LLC
Category
Medical Device — Endotracheal Tube
Hazard
Affected units
244,120

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 4026704547630
  • Batch Numbers: 18FG03
  • 18FG05
  • 18FG13
  • 18GG14
  • 18HG22
  • 18HG38
  • 18IG09
  • 18JG06
  • 18JG14
  • 18JG26
  • 18KG09
  • 18KG15
  • 18KG23
  • 18LG05
  • 18LG12
  • 18LG18
  • 19AG05
  • 19AG31
  • 19BG01

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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