# FDA recall Z-0527-2022

> **Velano Vascular** · Class II · device recall initiated 2021-11-10.

## Product

PIVO Blood Collection Device 20G, REF: 202-0005

## Reason for recall

Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.

## Distribution

US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.

## Key facts

- **Recall number:** Z-0527-2022
- **Recalling firm:** Velano Vascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-10
- **Report date:** 2022-02-02
- **Termination date:** 2023-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0527-2022

## Citation

> AI Analytics. FDA recall Z-0527-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0527-2022. Source: US FDA. Licensed CC0.

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