The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1924-2023·Announced 2023-07-05

Teleflex Endotracheal Tubes Recalled for 15mm Connector Disconnection

Teleflex is recalling Preformed AGT Oral Endotracheal Tubes due to reports of the 15mm connector disconnecting from the tube. Approximately 2,980 units were 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 is an FDA Class I recall, which requires a minimum severity score of 4 per agency classification rules. The hazard involves potential disconnection of a critical airway management device; however, no patient injuries or deaths have been reported in the source text.

Plain-English summary

Teleflex LLC is recalling Preformed AGT Oral Endotracheal Tubes (uncuffed/plain Murphy model, REF 100181065) due to reports of disconnection of the 15mm connector from the tube.

The affected devices have been distributed nationwide, including Puerto Rico, with approximately 2,980 units recalled. Specific batch numbers and UDI/DI codes for the recalled products are available from the FDA.

Disconnection of the connector from an endotracheal tube during use could compromise proper airway management and ventilation support, which are critical functions in anesthesia and intensive care settings.

Healthcare facilities and clinical staff with affected devices should contact Teleflex for handling instructions and follow their internal device recall protocols.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airways
Hazard
Affected units
2,980

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 (17)

  • UDI/DI 14026704340597
  • Batch Numbers: 18FT35
  • 18GG25
  • 18JG35
  • 18KG21
  • 18LG18
  • 19AG25
  • 19CT33
  • 19ET69
  • 20BT02
  • 20CT11
  • KME22B1670
  • KME22E1010
  • KME22E1408
  • KME22H0137
  • KME22J0202
  • KME22K2262

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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