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) 5045…

Recall date

July 16, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2320-2021

FDA classification

Class II

Brand / firm

Teleflex Medical Europe Ltd

Sold / distributed

US Nationwide distribution.

Why it was recalled

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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