Recall Z-2320-2021— Teleflex Medical Europe Ltd

Name: FDA recall Z-2320-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-16

Class II · Ongoing

Class II FDA medical device recall by Teleflex Medical Europe Ltd, initiated 2021-07-16. It names one FDA 510(k) clearance: K961837. 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. Reason: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat..

Recalling firm: Teleflex Medical Europe Ltd
Classification: Class II
Status: Ongoing
Initiated: 2021-07-16
Firm location: Athlone, N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K961837 — RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHYRusch Intl.·cleared 1996-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.