PIVO Blood Collection Device 20G, REF: 202-0005 recallZ-0527-2022 · Velano Vascular · initiated Nov 10, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Velano Vascular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
On 11/10/21, recall notices were sent to Medical Directors, Risk Managers, Medical Device Safety Officers, Nurse Managers. 1) Locate and destroy all product subject to the recall following your institution s process for destruction. 2) If the affected product was previously used in patient care and no signs of infection are apparent, no additional steps need to be taken. If the affected product was used in patient care and signs of infection are present, follow your institution s established procedures. 3) Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. If you further distributed product, identify customers within your distribution network that purchased the affected product, as defined in this recall notification. Email an excel file listing of all customers to [email protected] so the recalling firm may initiate customer notification. 4) Complete and return the Distributor Response Form. Customers require further assistance are encouraged to call/email: 1-844-823-5433/ [email protected]
Recall details
- Recall number
- Z-0527-2022
- Status
- Terminated
- Initiated by the company
- Nov 10, 2021
- Recalling firm
- Velano Vascular
- Quantity
- 123,700
- Product code
- JKA
- FDA submissions
- K193569
- Distribution
- US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
Product description
PIVO Blood Collection Device 20G, REF: 202-0005
Code information (models, lots, serial numbers)
UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PIVO 20G 202-0005Velano Vascular, Inc. · Tubes, Vials, Systems, Serum Separators, Blood Collection1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page