The Recall Desk
SevereFDA (Devices)·Z-1867-2023·Announced 2023-07-05

TELEFLEX Preformed Endotracheal Tube Connector Disconnection Nationwide Recall

TELEFLEX LLC is recalling 2,714 preformed endotracheal tubes nationwide due to reports of 15mm connector disconnection. This hazard may prevent proper connection to ventilation equipment.

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 classification requires a minimum severity score of 4. While no deaths or hospitalizations are reported in the source, the risk of connector disconnection on a critical respiratory device during patient care justifies a Severe rating.

Plain-English summary

TELEFLEX LLC is recalling 2,714 units of the Preformed AGT Oral Endotracheal Tube (uncuffed/plain - Murphy, REF 100180060) distributed nationwide, including Puerto Rico. These medical devices are used in anesthesia and mechanical ventilation to maintain open airways.

Reports indicate disconnection of the 15mm connector from the endotracheal tube. A disconnected connector could prevent proper attachment of the tube to ventilation equipment and may compromise patient airway management.

The recalled batches are identified by UDI/DI 14026704340498 and the following batch numbers: 18KG08, 18LG33, 19AG21, 19BG12, 19ET12, 19FT19, 19HT34, 19IT12, 19IT43, 19LT32, 20AT49, 20DT15, 20GG27, KME20K1813, KME20L2063, KME20M1586, KME21A2393, KME21C3189, KME22D3370, KME22F2673.

Healthcare providers should contact TELEFLEX and the FDA for guidance on the affected batches, including information about whether these devices should be used and options for replacement or return.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Anesthesia
Hazard
Affected units
2,714

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 14026704340498
  • Batch Numbers: 18KG08
  • 18LG33
  • 19AG21
  • 19BG12
  • 19ET12
  • 19FT19
  • 19HT34
  • 19IT12
  • 19IT43
  • 19LT32
  • 20AT49
  • 20DT15
  • 20GG27
  • KME20K1813
  • KME20L2063
  • KME20M1586
  • KME21A2393
  • KME21C3189
  • KME22D3370

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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