The Recall Desk
SevereFDA (Devices)·Z-1871-2023·Announced 2023-07-05

Preformed AGT Endotracheal Tubes Recalled for Connector Disconnection Risk

Teleflex is recalling 12,852 units of Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection from the tube. Affected units were distributed nationwide 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 classified this recall as Class I. The rubric specifies that FDA Class I recalls must score no lower than 4. Although no illnesses or injuries are reported, connector disconnection from an endotracheal tube poses serious potential for respiratory compromise during patient care.

Plain-English summary

Teleflex LLC is recalling 12,852 units of Preformed AGT Oral Endotracheal Tubes (uncuffed/plain - Murphy style, REF 100181040). These products were distributed nationwide throughout the United States and Puerto Rico.

The recall is being issued due to reports of disconnection of the 15mm connector from the endotracheal tube. Connector separation during use could disrupt respiratory therapy and airway management for patients requiring intubation or ventilation.

Affected batch numbers include 18GG17, 18GG34, 18IG15, 18JG03, 18JG21, 18KG18, 18LG14, 18LG15, 19AG25, 19BG02, 19ET39, 19FT46, 19HT31, 19IT01, 19IT53, 19KT02, 19LT21, 20AT26, 20CT11, 20DT19, 20DT32, KME20J0427, KME20M0303, KME21A2096, KME21A3064, KME21B2620, KME21B2621, KME21C1148, KME21C3436, KME21D0720, KME21D2148, KME21M2369, KME22B0041, KME22B0278, KME22B0588, KME22C0507, KME22D3254, KME22F0607, and KME22F2175. Products can also be identified using UDI/DI code 14026704340542.

Concerns or reports of adverse events related to these products should be directed to Teleflex LLC or the FDA.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management Equipment
Hazard
Affected units
12,852

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 14026704340542
  • Batch Numbers: 18GG17
  • 18GG34
  • 18IG15
  • 18JG03
  • 18JG21
  • 18KG18
  • 18LG14
  • 18LG15
  • 19AG25
  • 19BG02
  • 19ET39
  • 19FT46
  • 19HT31
  • 19IT01
  • 19IT53
  • 19KT02
  • 19LT21
  • 20AT26
  • 20CT11

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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