FDA recall Z-2322-2021

Teleflex Medical Europe Ltd · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-07-16
Report date
2021-08-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athlone, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2021