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

Recall date

November 10, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0527-2022

FDA classification

Class II

Brand / firm

Velano Vascular

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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