# FDA recall Z-3213-2017

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2017-08-14.

## Product

UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ      The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.

## Reason for recall

Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.

## Distribution

INTERNATIONAL ONLY:  GB, FR, AT, DE, IT, SE, IE, BE, ES, LU

## Key facts

- **Recall number:** Z-3213-2017
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-14
- **Report date:** 2017-10-04
- **Termination date:** 2019-06-18

- **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-3213-2017

## Citation

> AI Analytics. FDA recall Z-3213-2017. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3213-2017. Source: US FDA. Licensed CC0.

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