FDA-Device2021-08-25Class II
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
Teleflex Medical Europe Ltd
Hazard
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Sold states
US Nationwide distribution.
Affected count
2610 units
Manufactured in
Ida Business Park, N/A, Athlone, N/A, Ireland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2021Don't want to check this manually?
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