Teleflex Preformed AGT Endotracheal Tubes Recalled for Connector Disconnection
Teleflex is recalling 670 units of Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection from the tube.
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 score of 4 per the rubric. No deaths, injuries, or hospitalizations have been reported; however, the connector disconnection defect in an endotracheal tube presents a potential hazard to airway management.
Plain-English summary
Teleflex LLC is recalling 670 units of the Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff (REF 111780085), distributed nationwide including Puerto Rico.
The recall was issued due to reports of disconnection of the 15mm connector from the endotracheal tube. The FDA classified this as a Class I recall. Affected units are identified by UDI/DI 14026704341136 and batch numbers: 18GG25, 18LG18, 19AG19, 19DT36, 20CT32, 20GT34, KME21B2675, KME21F0887, and KME22H1797.
Healthcare facilities and medical providers should identify affected units in their inventory using the UDI/DI and batch numbers provided. For instructions on returns, replacements, or other guidance, contact Teleflex LLC or the FDA. The FDA recall number is Z-1949-2023.
The recalled product
- Product
- Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
- 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 (10)
- UDI/DI 14026704341136
- Batch Numbers: 18GG25
- 18LG18
- 19AG19
- 19DT36
- 20CT32
- 20GT34
- KME21B2675
- KME21F0887
- KME22H1797
Distribution
Distributed nationwide across the United States.
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