FDA-Device2021-08-25Class II
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
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
638220 units
Manufactured in
Ida Business Park, N/A, Athlone, N/A, Ireland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2021Don't want to check this manually?
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