Endotracheal Tubes Recalled Due to Connector Disconnection Risk
Teleflex LLC is recalling 17,840 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. These tubes have been 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: This FDA Class I device recall meets the threshold for Severe classification. Per the rubric, FDA Class I recalls never fall below a score of 4. The connector disconnection in an endotracheal tube poses a serious hazard during patient care, though no injuries or illnesses have been reported.
Plain-English summary
Teleflex LLC is recalling approximately 17,840 Preformed AGT Oral Endotracheal Tubes, Model REF 111781075, with Murphy Eye, High Volume, Low Pressure Cuff. These are medical devices used for airway management in intubated patients.
The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube. The FDA has classified this as a Class I recall, which designates it as a defect or noncompliance that poses a serious hazard to health.
The affected tubes were distributed nationwide, including Puerto Rico. Approximately 17,840 units are affected across multiple batch numbers from 2018 through 2023. The UDI/DI for these products is 14026704341235.
The recalled product
- Product
- Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075
- 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 14026704341235
- Batch Numbers: 18FG21
- 18GG18
- 18GG19
- 18HG29
- 18IG17
- 18JG03
- 18JG20
- 18JG35
- 18KG01
- 18KG43
- 18LG18
- 19AG25
- 19BG03
- 19BG18
- 19BG20
- 19DT38
- 19ET36
- 19FT02
- 19HT55
Distribution
Distributed nationwide across the United States.
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