FDA-Device2021-08-25Class II
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
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
155030 units
Manufactured in
Ida Business Park, N/A, Athlone, N/A, Ireland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2021Don't want to check this manually?
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