Recall Z-0527-2022— Velano Vascular
Class II · Terminated
Class II FDA medical device recall by Velano Vascular, initiated 2021-11-10, terminated 2023-07-31. It names one FDA 510(k) clearance: K193569. Product: PIVO Blood Collection Device 20G, REF: 202-0005. 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..
- Recalling firm
- Velano Vascular
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-10
- Terminated
- 2023-07-31
- Firm location
- San Francisco, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PIVO Blood Collection Device 20G, REF: 202-0005
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.