FDA recall Z-2321-2021

Product

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

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-2321-2021