Z-1408-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2015
- Initiation Date
- March 30, 2015
- Termination Date
- April 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
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.
Distribution Pattern
US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
Code Information
Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, GB40186