Recall Z-1408-2015 ยท OBJ Catheter, Ultrasound, Intravascular
VasoNova, Inc.
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.
| Date | Apr 9, 2015 (initiated Mar 30, 2015) |
| Status | Terminated |
| Reason | A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 17 |
| Distribution | US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE Vasonova, Inc., Jan 18, 2013 |