The Recall Desk
SevereFDA (Devices)·Z-1932-2023·Announced 2023-07-05

Teleflex Endotracheal Tubes: FDA Recalls 1110 Units for Connector Disconnection

Teleflex is recalling 1,110 endotracheal tubes due to reports of 15mm connector disconnection. The affected units are distributed nationwide in the US and 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: This is an FDA Class I recall. Per the rubric, FDA Class I recalls carry a minimum severity score of 4. No reported deaths are documented, so the score does not qualify for the Critical (5) category.

Plain-English summary

Teleflex LLC is recalling 1,110 endotracheal tubes (Magill brand, REF 100380060, UDI/DI 14026704340689) distributed nationwide in the US and Puerto Rico. The affected batch numbers are: 18FG31, 19BT11, 19ET72, 19JT30, 20AT13, 20BT13, 20DT13, KME21D0600, KME21J0790, KME22A0448, and KME22D1803.

The company has received reports of disconnection of the 15mm connector from the endotracheal tube for the affected products. An endotracheal tube is a critical medical airway device used to manage airways during anesthesia and mechanical ventilation in hospital settings.

Healthcare facilities and medical professionals who have received these products should review their inventory and identify any affected units. Disconnection of the connector could compromise airway management and patient safety. Contact Teleflex LLC regarding the affected devices. Any adverse events related to this product should be reported to the FDA.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
1,110

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 (12)

  • UDI/DI 14026704340689
  • Batch Numbers: 18FG31
  • 19BT11
  • 19ET72
  • 19JT30
  • 20AT13
  • 20BT13
  • 20DT13
  • KME21D0600
  • KME21J0790
  • KME22A0448
  • KME22D1803

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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