Flexi-Set Endotracheal Tubes Recalled Due to Connector Disconnection Risk
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of the 15mm connector disconnecting from the tube, posing a serious risk 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 is an FDA Class I medical device recall. Per the severity rubric, FDA Class I classifications cannot score below 4, as they indicate a serious health risk requiring immediate attention.
Plain-English summary
TELEFLEX LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504585) nationwide, including Puerto Rico. The recall was issued because the 15mm connector can disconnect from the endotracheal tube. This disconnection poses a serious risk for patients who depend on these tubes for airway management during medical procedures and critical care.
Approximately 56,640 units were distributed. The affected products can be identified by UDI/DI 4026704547647. Multiple batch numbers are affected, spanning from 2018 through 2022.
Healthcare providers who have this product should verify their stock against the list of affected batch numbers available in the FDA recall notice. Facilities should follow TELEFLEX LLC's guidance for product replacement and handling of existing inventory to prevent use of affected units.
The recalled product
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
- 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 4026704547647
- Batch Numbers: 18FG13
- 18FG15
- 18FG25
- 18GG20
- 18GG28
- 18HG12
- 18HG19
- 18IG06
- 18IG27
- 18JG02
- 18JG23
- 18JG26
- 18KG18
- 18KG23
- 19AG05
- 19AG31
- 19AG37
- 19CT17
- 19CT58
Distribution
Distributed nationwide across the United States.
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