Velano Vascular recalls PIVO Blood Collection Device 20G (REF: 202-0005) due to potential microbial contamination from incomplete sterile packaging. Affected units include specific production lots sold between May 2021 and July 2021.
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.
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Contact the company
📍Recalling firmVelano Vascular221 Pine St # 200 · San Francisco, CA 94104-2705
✎ GovInfoNow plain-language explainer
Velano Vascular is recalling PIVO Blood Collection Devices with model REF: 202-0005 because the packaging may not seal properly, risking microbial contamination before use. This could lead to bloodstream infections if the device is used without proper sterility. Read more at govinfonow.com/recall/61553-velano-pivo-blood-collection-device-20g-recall-risk-of-microbial.
“Velano PIVO Blood Collection Device 20G Recall: Risk of Microbial Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61553-velano-pivo-blood-collection-device-20g-recall-risk-of-microbial. Based on FDA recall #Z-0527-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0527-2022%22&limit=1).
The FDA announced on November 10, 2021, that Velano Vascular is recalling PIVO Blood Collection Device 20G units due to potential sterile barrier breaches. This defect may allow microbial contamination of the device prior to use.
Distribution: US Nationwide in CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC
The hazard
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.
Context
GovInfoNow's records show other recent recalls of similar products include Medline IVS Blood Culture Kits Recall (2026-06-12) and Medline Blood Culture Kits Recall (2026-06-12). Additional related actions involve the Medline Convenience Kits Recall (2026-06-12) citing risk of microbial contamination from packaging wrinkles.
How to tell if you have this one
Check for the model REF: 202-0005 on the device. Affected units include production lots labeled 051421-02 through 070621-02 sold between May 2021 and July 2021.
Brand
Velano Vascular
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Packaging
Look for the model REF: 202-0005 and production lots 051421-02 through 070621-02 on the device packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Connecticut, Florida, Illinois, Michigan, New Jersey, North Carolina, Pennsylvania, Utah, Washington.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Ensure the device packaging is sealed properly before use. If you have the recalled model, check the production lot number and follow the manufacturer's instructions for safe use.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0527-2022 (November 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0527-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.