Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PIVO Blood Collection Device 20G Recalled by Velano Vascular Due to Incomplete sealing of blood collection device unit packages...

Date: November 10, 2021
Company: Velano Vascular
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Velano Vascular directly.

Affected Products

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

Quantity: 123,700

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Velano Vascular

Velano Vascular has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report