The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1869-2023·Announced 2023-07-05

Preformed AGT Oral Endotracheal Tubes recalled for risk of connector disconnection

TELEFLEX is recalling Preformed AGT Oral Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. The affected product has been distributed nationwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall was classified as FDA Class I, indicating a reasonable probability that the product could cause serious adverse health consequences. The hazard (connector disconnection) involves a critical airway management device where separation during use could be life-threatening.

Plain-English summary

Preformed AGT Oral Endotracheal Tubes (uncuffed/plain - Murphy, REF 100180070) manufactured by TELEFLEX LLC are being recalled due to reports of disconnection of the 15mm connector from the endotracheal tube.

The 15mm connector is essential for connecting the endotracheal tube to respiratory equipment and ventilation circuits. A disconnection could compromise patient airway access and create a serious risk during mechanical ventilation.

The recall affects 970 units distributed nationwide in the United States and Puerto Rico. Affected batch numbers are: 18HG40, 18LG33, 19CT36, 19FT19, 19GT46, 19LT31, KME21A2555, KME22H2313, and KME22K1045. The product is identified by UDI/DI 14026704340511.

Healthcare facilities and medical professionals should immediately verify their inventory against the affected batch numbers and discontinue use of any recalled units. Contact TELEFLEX LLC for instructions on returns or replacement products.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway Management
Hazard
Affected units
970

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 (10)

  • UDI/DI 14026704340511
  • Batch Numbers: 18HG40
  • 18LG33
  • 19CT36
  • 19FT19
  • 19GT46
  • 19LT31
  • KME21A2555
  • KME22H2313
  • KME22K1045

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 →

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