The Recall Desk
SevereFDA (Devices)·Z-1946-2023·Announced 2023-07-05

Preformed AGT oral endotracheal tube connector disconnection recalled

Teleflex LLC recalls 14,780 preformed AGT oral endotracheal tubes due to reports of 15mm connector disconnection. 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 is an FDA Class I recall. According to the severity rubric, FDA Class I recalls must score no lower than 4. Disconnection of a critical connector on an airway management medical device represents a serious hazard.

Plain-English summary

Teleflex LLC is recalling the preformed AGT oral endotracheal tube with Murphy eye, high volume, low pressure cuff (REF 111780065) due to reports of disconnection of the 15mm connector from the endotracheal tube. Endotracheal tubes are medical devices used for airway management during intubation and mechanical ventilation.

Approximately 14,780 units have been distributed throughout the United States and Puerto Rico. The affected devices are identified by UDI/DI 14026704341099 and specific batch numbers listed in the recall notice.

The connector disconnection could affect the proper functioning of the device during clinical use. Anyone with affected units should check the batch numbers to determine if their inventory is included in this recall.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway Management
Hazard
Affected units
14,780

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 14026704341099
  • Batch Numbers: 18FG12
  • 18FG23
  • 18FG24
  • 18GT26
  • 18HG24
  • 18IG11
  • 18IG14
  • 18IG24
  • 18JG07
  • 18JG36
  • 18KG10
  • 18LG11
  • 18LG31
  • 19AG11
  • 19AG36
  • 19CT36
  • 19DT10
  • 19ET12
  • 19FT18

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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