RUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication
Teleflex recalls RUSCH endotracheal tubes because the cuff can be inflated while the pilot balloon remains flat, preventing proper monitoring of cuff pressure.
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 Class II medical device malfunction presents a risk of harm in critical care settings, specifically the inability to properly monitor cuff pressure during endotracheal tube use. No injuries or hospitalizations have been reported in the source text, consistent with a High severity rating for risk-of-harm products where injury has not yet been documented.
Plain-English summary
Teleflex Medical Europe Ltd is recalling RUSCH Endotracheal Tubes with High Volume, Low Pressure Cuffs and Murphy Eyes in multiple sizes. The recall affects 638,220 units distributed nationwide in the United States across ten different reference numbers (REF 112082050 through 112082100).
The firm received reports that these endotracheal tubes have a defect in which the cuff can be inflated while the pilot balloon—the visual indicator of cuff pressure—remains flat. This malfunction prevents proper assessment of cuff inflation status during use.
Healthcare facilities and clinicians using affected lots should immediately cease use of the recalled tubes and verify inventory against the specific lot numbers listed in the recall. Patients already intubated with affected tubes should have them replaced if the malfunction is identified. Contact Teleflex for device returns and replacement instructions.
The recalled product
- Product
- RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100
- Manufacturer
- Teleflex Medical Europe Ltd
- Affected units
- 638,220
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) 112082050
- Lot Numbers: KME20K0211
- KME20K0463
- KME21A2017
- KME21A2343
- KME21A2686
- KME21B2491 b) 112082055
- Lot Numbers: KME20K0464
- KME20K0683
- KME20L1703
- KME20M0996
- KME21A0492
- KME21A1433
- KME21C0502
- KME21C1347
- KME21C1496
- KME21C2745
- KME21D0835 c) 112082060
- Lot Numbers: KME20K0435
- KME20K1112
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 Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction
FDA (Devices) · 2021-08-25
- 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
- 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