# FDA recall Z-0497-2021

> **Flexicare Medical Ltd.** · Class I · device recall initiated 2020-09-22.

## Product

ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5      *Note: product list updated per 12/23/2020 letter to customers

## Reason for recall

When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-0497-2021
- **Recalling firm:** Flexicare Medical Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-22
- **Report date:** 2020-12-02
- **Termination date:** 2024-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rhondda Cynon Taff, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0497-2021

## Citation

> AI Analytics. FDA recall Z-0497-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0497-2021. Source: US FDA. Licensed CC0.

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