Recall Z-1408-2015— VasoNova, Inc.
Class II · Terminated
Class II FDA medical device recall by VasoNova, Inc., initiated 2015-03-30, terminated 2016-04-11. It names one FDA 510(k) clearance: K123813. Product: VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.. Reason: A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1..
- Recalling firm
- VasoNova, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-30
- Terminated
- 2016-04-11
- Firm location
- Menlo Park, 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
VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Reason for recall
A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
Data sourced from openFDA. This site is unofficial and independent of the FDA.