The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1898-2023·Announced 2023-07-05

RUSCHELIT Safety Clear Tracheal Tube 15mm Connector Disconnection Recall

TELEFLEX is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reported disconnection of the 15mm connector, affecting approximately 37,076 units 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I medical device recall. The FDA Class I designation, per the severity rubric, applies to devices where failure could cause serious adverse health consequences and warrants a Critical severity rating.

Plain-English summary

TELEFLEX LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes (oral/nasal configuration, model REF 112480040). The recall involves approximately 37,076 units with specific batch numbers distributed nationwide, including Puerto Rico.

The recall was initiated following reports of disconnection of the 15mm connector from the endotracheal tube. A disconnected connector could compromise the integrity of the airway management system during medical use.

Healthcare facilities and providers should check their inventory against the provided batch numbers to identify any affected units. For information regarding next steps, replacement options, or further instructions, they should contact TELEFLEX LLC.

The recalled product

Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
37,076

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 14026704341525
  • Batch Numbers: 18FG14
  • 18FG22
  • 18JG08
  • 18KG25
  • 18LG04
  • 18LG30
  • 19DT35
  • 19DT36
  • 19ET09
  • 19ET31
  • 19ET51
  • 19HT60
  • 19IT32
  • 19IT43
  • 20AT06
  • 20AT39
  • 20BT01
  • 20BT53
  • 20CT12

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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