The Recall Desk
SevereFDA (Devices)·Z-1896-2023·Announced 2023-07-05

Tracheal tube connector disconnection reported in RUSCHELIT Safety Clear models

TELEFLEX LLC is recalling RUSCHELIT Safety Clear Tracheal Tubes due to reports of 15mm connector disconnection. The recall involves 21,284 units distributed nationwide.

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: The FDA has classified this as a Class I recall, the most serious medical device classification. While no illnesses or injuries are reported in the source text, the critical function of the tracheal tube in airway management justifies this classification.

Plain-English summary

TELEFLEX LLC is recalling the RUSCHELIT Safety Clear Tracheal Tube, oral/nasal Magill design (REF 112480030). This endotracheal tube is used for airway management in medical settings. Affected units are identified by UDI/DI 14026704341501 and include multiple batch numbers listed in the recall notice.

The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube, which is critical for maintaining proper airway support.

Approximately 21,284 units were distributed nationwide, including Puerto Rico. Healthcare facilities and medical professionals who received these tubes should check their inventory against the list of affected batch numbers.

Users should immediately discontinue use of affected batches and contact TELEFLEX LLC for replacement units or return instructions. Any adverse events related to this product should be reported to the FDA.

The recalled product

Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030
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 14026704341501
  • Batch Numbers: 18GG16
  • 18HG10
  • 18HG25
  • 18IG03
  • 19BG12
  • 19BG16
  • 19CT42
  • 19CT64
  • 19DT36
  • 19ET09
  • 19ET31
  • 19ET53
  • 19GT02
  • 19IT38
  • 19JT21
  • 19JT55
  • 19KT20
  • 19KT37
  • 19LT31

Distribution

Distributed nationwide across the United States.