RUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction
Teleflex Medical Europe is recalling RUSCH endotracheal tubes because the cuff can inflate without the pilot balloon showing proper inflation. This defect could prevent clinicians from verifying correct cuff function.
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 a risk-of-harm medical device (endotracheal tube used in critical airway management) with a functional defect that prevents proper verification of cuff inflation. However, no injuries or illnesses have been reported in the source text, placing it in the 'High' category per the FDA severity rubric.
Plain-English summary
Teleflex Medical Europe Ltd is recalling specific lots of RUSCH Endotracheal Tubes (High Volume, Low Pressure Cuff) distributed nationwide in the United States. A total of 2,610 units are affected across ten reference numbers.
The manufacturer received reports that the endotracheal tube cuff can be inflated while the pilot balloon remains flat. The pilot balloon is the standard indicator that the cuff has been properly inflated. If the pilot balloon fails to inflate while the cuff itself inflates, clinicians cannot verify whether the cuff is functioning correctly.
This recall affects healthcare facilities and medical professionals who use these tubes in airway management procedures. Affected lot numbers have been identified by the FDA. Healthcare providers should identify and quarantine any affected units and consult with Teleflex Medical Europe Ltd and the FDA for further instructions on inspection, return, or replacement.
The recalled product
- Product
- RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100
- Manufacturer
- Teleflex Medical Europe Ltd
- Affected units
- 2,610
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) 112080050
- Lot Numbers: KME20K1512
- KME20L1145
- KME20M2383
- KME21B0357 b) 112080055
- Lot Numbers: KME20K2579
- KME21A2569
- KME21C1978 c) 112080060
- Lot Numbers: KME20M0616
- KME20M2112
- KME21A2685 d) 112080065
- Lot Numbers: KME20K2581
- KME21C1701 e) 112080070
- Lot Numbers: KME20K2577
- KME20L1985
- KME20M1771
- KME20M1772
- KME20M2856
- KME21A2355
- KME21B1624
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teleflex Medical Europe Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Teleflex Medical Europe Ltd
See all →- HighRUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response
FDA (Devices) · 2021-08-25
- HighRUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation
FDA (Devices) · 2021-08-25
- HighRUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication
FDA (Devices) · 2021-08-25
- HighTeleflex Universal Shears Recalled Due to Handle Melting During Sterilization
FDA (Devices) · 2018-07-04
- ModerateTeleflex Laryngo-Tracheal Mucosal Atomization Device Recalled for Labeling Defects
FDA (Devices) · 2018-05-09
Same hazard · cuff malfunction
See all →- HighTeleflex Endotracheal Tubes Recalled for Potential Cuff and Balloon Dysfunction
FDA (Devices) · 2023-02-01