Flexi-Set Endotracheal Tube Connector May Disconnect During Use
Teleflex is recalling 244,120 Flexi-Set Cuffed Endotracheal Tubes due to reports that the 15mm connector may disconnect 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: This FDA Class I recall for a structural connector defect on a critical airway device requires a minimum severity score of 4 per the rubric. No illnesses or injuries are reported in the source material.
Plain-English summary
Teleflex LLC is recalling 244,120 units of the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504580) for oral and nasal use. The recall is due to reports of disconnection of the 15mm connector from the endotracheal tube.
The affected units were distributed nationwide, including Puerto Rico. Batch numbers and product codes for the recall are specified by the FDA.
Healthcare facilities using these tubes should verify their inventory against the FDA recall list. For further information and recommended actions, consult the FDA's official recall notice or contact Teleflex directly.
The recalled product
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
- Manufacturer
- TELEFLEX LLC
- Hazard
- connector-disconnect
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 4026704547630
- Batch Numbers: 18FG03
- 18FG05
- 18FG13
- 18GG14
- 18HG22
- 18HG38
- 18IG09
- 18JG06
- 18JG14
- 18JG26
- 18KG09
- 18KG15
- 18KG23
- 18LG05
- 18LG12
- 18LG18
- 19AG05
- 19AG31
- 19BG01
Distribution
Distributed nationwide across the United States.
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