Endotracheal Tubes Recalled for Potential 15mm Connector Disconnection
TELEFLEX is recalling 4,160 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. Affected units were distributed nationwide.
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 mandates a minimum severity rating of 4. Although no deaths, hospitalizations, or injuries have been reported, connector disconnection on an endotracheal tube presents serious potential harm.
Plain-English summary
TELEFLEX LLC is recalling 4,160 units of Endotracheal Tubes oral/nasal Magill with High Volume, Low Pressure Cuff (model REF 112080060). Reports indicate that the 15mm connector can disconnect from the endotracheal tube.
The affected tubes were distributed nationwide throughout the United States and Puerto Rico across multiple batch numbers.
The FDA classified this as a Class I recall, the most serious category. Healthcare providers and patients currently using these tubes should stop use and contact TELEFLEX LLC immediately for guidance on replacement or safe handling. Any adverse events should be reported to the FDA.
The recalled product
- Product
- Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
- Manufacturer
- TELEFLEX LLC
- Hazard
- connector-disconnection
- equipment-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/DI 14026704341266
- Batch Numbers: 18GG26
- 18GT08
- 18GT11
- 18IG22
- 18IT18
- 18JG33
- 19AG39
- 19ET31
- 19GT25
- 19IT20
- 19KT14
- 19KT47
- 20AT58
- 20CT13
- 20FT66
- KME20J1463
- KME21K0521
- KME22A2893
- KME22B2215
Distribution
Distributed nationwide across the United States.
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