Recall Z-1408-2015
VasoNova, Inc. · initiated March 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, GB40186
Reason for recall
A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
FDA-determined cause: Device Design
Action taken
Teleflex sent an Urgent Medical Device Recall Notification letters dated on March 30, 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. The risk to users is identified and users are asked to discontinue use and quarantine affected serial numbers. Teleflex sales reps will help with return of product. The Acknowledgeable form should be completed and returned as per instructions. Questions should be directed to 1.877.236.6869.
Details
- Recall number
- Z-1408-2015
- Initiated
- March 30, 2015
- Posted by FDA
- April 9, 2015
- Terminated
- April 11, 2016
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 17
- Distribution
- US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
- Recalling firm
- VasoNova, Inc., Menlo Park, CA