FDA Medical Device Recalls (openFDA)
Velano Vascular: PIVO Blood Collection Device 20G, REF: 202-0005
- Recall number
- Z-0527-2022
- Recalling firm
- Velano Vascular
- Product
- PIVO Blood Collection Device 20G, REF: 202-0005
- Status
- Terminated
- Initiated
- 2021-11-10
- Posted
- not on file
- Terminated
- 2023-07-31
- Reason
- 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.
- Root cause
- Process control
- Action
- 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 BDRC9@bd.com 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/ productcomplaints@bd.com
- Quantity
- 123,700
- Distribution
- US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
- Lot, serial or model codes
- UDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02
- 510(k) numbers
- ["K193569"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 1710034
- Firm city
- San Francisco
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28