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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
- 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 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.
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