The Recall Desk
SevereFDA (Devices)·Z-1848-2023·Announced 2023-07-05

Endotracheal Tube Sets Recalled for Connector Disconnection Risk

Teleflex is recalling Flexi-Set Cuffed Endotracheal Tube Sets due to reported 15mm connector disconnection. The recall affects 92,930 units distributed throughout the United States, including Puerto Rico.

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 Class I recalls require a minimum severity score of 4, indicating a reasonable probability of serious adverse health consequences. The connector disconnection represents a documented equipment malfunction on critical airway management devices. No illnesses or deaths have been reported.

Plain-English summary

Teleflex LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (oral/nasal, REF 504565) due to received reports of disconnection of the 15mm connector from the endotracheal tube.

The recalled product was distributed throughout the United States, including Puerto Rico. Approximately 92,930 units were distributed. The affected products can be identified by UDI/DI 4026704547609 and specific batch numbers provided in the FDA recall notice.

Endotracheal tubes are critical medical devices used in anesthesia and intensive care. The reported connector disconnection could affect device function during use.

Healthcare providers should identify affected inventory using the batch numbers and take appropriate action regarding the recalled units. Teleflex should be contacted for information on replacement products or retrieval of recalled devices. This recall has been classified by the FDA as Class I, indicating the potential for serious adverse health consequences.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management Equipment
Hazard
Affected units
92,930

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 4026704547609
  • Batch Numbers: 18FG05
  • 18FG13
  • 18FG25
  • 18GG20
  • 18HG07
  • 18HG12
  • 18HG19
  • 18HG32
  • 18HG38
  • 18IG06
  • 18IG09
  • 18IG15
  • 18JG04
  • 18JG21
  • 18JG34
  • 18KG35
  • 18LG39
  • 19AG01
  • 19AG24

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

See all →

Same hazard · connector disconnection

See all →