RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response
Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a functional malfunction in a critical airway management device. No illnesses, injuries, or deaths are reported. Per the severity rubric, when no harm has been reported and the hazard is functional rather than resulting in direct injury, the maximum score is 3 (High).
Plain-English summary
Teleflex Medical Europe Ltd is recalling the RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set for oral and nasal use. Approximately 155,030 units have been distributed nationwide in clinical settings.
The company received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. This represents a malfunction where the indicator may not reflect the actual cuff status during use.
Healthcare providers using affected products should review the recall notice for specific lot numbers and contact Teleflex Medical Europe Ltd for guidance on discontinuation and replacement of affected units.
The recalled product
- Product
- RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
- Manufacturer
- Teleflex Medical Europe Ltd
- Hazard
- device-malfunction
- monitoring-defect
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)
- a) 504550
- Lot Numbers: KME20K0001
- KME20K0467
- KME20K1581
- KME20L0618
- KME20L1090
- KME20L2027
- KME20M0019
- KME21A2076
- KME21A2787
- KME21B1140
- KME21C0059
- KME21C2363 b) 504555
- Lot Numbers: KME20K0765
- KME20K0766
- KME20K0935
- KME20K1582
- KME20L0619
- KME20L1857
- KME20L2028
Distribution
Distributed nationwide across the United States.
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