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Teleflex Medical Europe Ltd recalls RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d
Recalled August 25, 2021 · FDA recall Z-2320-2021 · Teleflex Medical Europe
Hazard
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. · FDA Class II
Units
155030 units
Sold at
US Nationwide distribution.
Description
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Product
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
Manufacturer(s)
Teleflex Medical Europe Ltd
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →