San Francisco, CA, United States
Velano Vascular recalls
1 recall recorded since 2018, most recently on 10 November 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 November 2021
- Terminated
- 31 July 2023
- 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.
- Distribution
- US Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0527-2022
- PIVO Blood Collection Device 20G, REF: 202-0005
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.