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.
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.
The blood collection device packaging may not seal completely, allowing microbes to enter the sterile product before use. This contamination could happen during manufacturing or shipping, potentially leading to bloodstream infections if the device is used without proper sterilization.
Healthcare professionals and patients using the PIVO Blood Collection Device 20G with specific production lots (051421-02 through 070621-02) from May 2021 to July 2021 are affected. Those with the device may face a risk of infection if the packaging was compromised.
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.
Look for the model REF: 202-0005 and production lots 051421-02 through 070621-02 on the device packaging.
The device may be safe if the packaging sealed properly, but affected units could have microbial contamination risk. Check the production lot number to confirm if it's recalled.
Check the device packaging for the model REF: 202-0005 and production lots 051421-02 through 070621-02. If it matches, contact Velano Vascular for guidance.
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.
We’ve drafted a message you can send Velano Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0527-2022 — Velano Vascular Velano Vascular Hello, I own a Velano Vascular that is covered by recall Z-0527-2022 from Velano Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
