Endotracheal Tube Connector Disconnection Recalled by Teleflex
Teleflex recalls 76,060 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. A disconnected connector could compromise ventilation in critical care 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: This FDA Class I medical device recall establishes a minimum severity of 4. Although connector disconnection poses a serious risk for ventilation compromise in critical care, no injuries or illnesses have been reported in the source material, preventing a higher classification.
Plain-English summary
Teleflex LLC is recalling 76,060 units of the Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff (REF 111781035). This device is an endotracheal tube used for airway management in medical and critical care settings.
The U.S. Food and Drug Administration has received reports of the 15mm connector disconnecting from the endotracheal tube. A disconnected connector could compromise ventilation, creating a serious risk for patients in critical care.
The affected devices were distributed nationwide throughout the United States, including Puerto Rico. Multiple batches from 2018 through 2022 production are affected, with the specific batch numbers listed on the FDA recall notice.
Healthcare facilities can use the product identifier UDI/I 14026704341150 along with the batch numbers on the FDA recall notice to identify affected devices in their inventory.
The recalled product
- Product
- Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035
- Manufacturer
- TELEFLEX LLC
- Hazard
- connector-disconnection
- ventilation-failure
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/I 14026704341150
- Batch Numbers: 18FG20
- 18FG31
- 18GG23
- 18GG34
- 18GT32
- 18HG17
- 18IG15
- 18JG01
- 18JG16
- 18JG35
- 18KG17
- 18KG18
- 18KG36
- 18LG15
- 18LG30
- 18LG39
- 19AG15
- 19BG33
- 19CG01
Distribution
Distributed nationwide across the United States.
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