The Recall Desk
Agency classClass IOur severity: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.

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: 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
Category
Medical Device — Airway Management
Hazard
Affected units
30,391

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.

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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