Endotracheal Tube Recalled for 15mm Connector Disconnection Risk
TELEFLEX LLC is recalling 9,070 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection. This medical device is used for airway management in hospital settings.
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 medical device recall (the most serious FDA classification), which establishes a minimum severity of 4 per the rubric. No illnesses, injuries, or deaths have been reported in the source text.
Plain-English summary
TELEFLEX LLC is recalling 9,070 units of Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff (REF 111780080) distributed nationwide, including Puerto Rico. The affected product is identified by UDI/DI 14026704341129 and includes specific lot and batch numbers documented by the FDA.
The recall is due to reports of disconnection of the 15mm connector from the endotracheal tube. An endotracheal tube is a medical device used for airway management and ventilation support in hospital and clinical settings. Connector disconnection could impair the device's function during critical patient use.
Healthcare facilities and providers should immediately verify their inventory against the affected lot numbers. Stop using the affected units and follow TELEFLEX LLC and FDA guidance for return or replacement instructions. Consult with your healthcare provider if you believe you have been exposed to a recalled device and have concerns about your care.
The recalled product
- Product
- Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
- 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 14026704341129
- Batch Numbers: 18FG33
- 18GG23
- 18GG34
- 18HG30
- 18IG11
- 18IG18
- 18JG21
- 18JG35
- 18KG19
- 18KG41
- 19AG15
- 19BG04
- 19BG19
- 19GT65
- 19HT68
- 19IT15
- 19LT21
- 20AT26
- 20CT12
Distribution
Distributed nationwide across the United States.
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