# FDA recall Z-2321-2021

> **Teleflex Medical Europe Ltd** · Class II · device recall initiated 2021-07-16.

## 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

- **Recall number:** Z-2321-2021
- **Recalling firm:** Teleflex Medical Europe Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-16
- **Report date:** 2021-08-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athlone, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2021

## Citation

> AI Analytics. FDA recall Z-2321-2021. Retrieved 2026-09-10 from https://api.ai-analytics.org/recall/Z-2321-2021. Source: US FDA. Licensed CC0.

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