Flexi-Set Endotracheal Tube Connectors Recalled Due to Disconnection Risk
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets due to reports of 15mm connector disconnection. Approximately 684,042 units were 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 recall is classified FDA Class I by the U.S. Food and Drug Administration. Per the severity rubric, FDA Class I recalls cannot be scored below Severe (4).
Plain-English summary
TELEFLEX LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (model REF 504575) following reports of disconnection of the 15mm connector from the endotracheal tube. The product is used for oral and nasal intubation.
Approximately 684,042 units were distributed nationwide across the United States, including Puerto Rico. The recall affects multiple batch numbers.
The U.S. Food and Drug Administration has classified this as a Class I recall.
The recalled product
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575
- 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 4026704547623
- Batch Numbers: 18FG05
- 18FG13
- 18FG30
- 18GG02
- 18GG08
- 18GG12
- 18GG17
- 18GG20
- 18GG28
- 18HG01
- 18HG12
- 18HG22
- 18HG27
- 18HG35
- 18HG38
- 18IG09
- 18IG17
- 18IG27
- 18IG30
Distribution
Distributed nationwide across the United States.
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