Endotracheal Tube Connector Disconnection Recall — Teleflex Preformed AGT Units
Teleflex is recalling 347,422 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The connector may separate from the tube during use.
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 classification establishes a minimum severity score of 4 per recall guidance rules. The source documents reports of 15mm connector disconnection but does not report any associated deaths, injuries, or hospitalizations.
Plain-English summary
Teleflex LLC is recalling Preformed AGT Oral Endotracheal Tubes (Model REF 111781040) distributed nationwide, including Puerto Rico. The recall affects 347,422 units. The product is identified by UDI/DI 14026704341167 and specific batch numbers spanning designations 18FT35 through 20GT34 and additional KME-series lots.
The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube. The connector may separate from the tube during clinical use. Healthcare facilities and providers should identify any affected units using the complete list of batch numbers provided by the FDA in the official recall notice and consult Teleflex or the FDA for guidance on handling these devices.
The recalled product
- Product
- Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040
- 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 14026704341167
- Batch Numbers: 18FT35
- 18GG16
- 18GG19
- 18GG23
- 18GG34
- 18GT32
- 18HG17
- 18HG21
- 18HG22
- 18HG29
- 18HG30
- 18IG15
- 18JG01
- 18JG03
- 18JG16
- 18JG19
- 18JG35
- 18JG37
- 18KG17
Distribution
Distributed nationwide across the United States.
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