# FDA recall Z-2946-2020

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2020-08-28.

## Product

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube    This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.

## Reason for recall

Label has the incorrect size for the tracheotomy tube.

## Distribution

US Distribution to state of: CT

## Key facts

- **Recall number:** Z-2946-2020
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-28
- **Report date:** 2020-09-16
- **Termination date:** 2021-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2946-2020

## Citation

> AI Analytics. FDA recall Z-2946-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2946-2020. Source: US FDA. Licensed CC0.

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