The Recall Desk
SevereFDA (Devices)·Z-1899-2023·Announced 2023-07-05

RUSCHELIT Safety Clear Tracheal Tubes Recalled for Connector Disconnection

TELEFLEX LLC recalls RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The Class I recall affects 30,391 units 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 Class I classification requires a minimum severity score of 4. Although no illnesses or injuries are reported, disconnection of a critical airway management device connector presents serious risk of adverse health consequences during patient care.

Plain-English summary

TELEFLEX LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes (oral/nasal, Magill, REF 112480045) due to reports of the 15mm connector disconnecting from the endotracheal tube.

This Class I medical device recall affects approximately 30,391 units with UDI/DI 14026704341532. Multiple batch numbers manufactured between 2018 and 2023 are affected. The product was distributed throughout the United States and Puerto Rico.

Disconnection of the connector could prevent proper airway management during patient care. Healthcare providers should immediately stop using affected units and contact TELEFLEX LLC regarding return, replacement, or proper disposal of recalled products.

The recalled product

Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection

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 14026704341532
  • Batch Numbers: 18FG02
  • 18FG14
  • 18GT16
  • 18HG37
  • 18IG13
  • 18KG34
  • 18LG03
  • 19AG04
  • 19AG08
  • 19AG23
  • 19AG38
  • 19BG35
  • 19CG05
  • 19DT09
  • 19FT12
  • 19IT38
  • 19JT19
  • 19JT21
  • 19KT58

Distribution

Distributed nationwide across the United States.