# FDA recall Z-0205-2024

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2023-08-22.

## Product

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

## Reason for recall

The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

## Distribution

Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA.  There was no government/military distribution.  Foreign distribution was made to Canada.

## Key facts

- **Recall number:** Z-0205-2024
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-22
- **Report date:** 2023-11-08

- **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-0205-2024

## Citation

> AI Analytics. FDA recall Z-0205-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0205-2024. Source: US FDA. Licensed CC0.

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