VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console
FDA device recall Z-1408-2015 · posted 2015-04-09 · Terminated
Recall details
- Recalling firm
- VasoNova, Inc.
- Reason for recall
- A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OBJ
- Quantity affected
- 17
- Distribution
- US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
- Date initiated
- 2015-03-30
- Date posted
- 2015-04-09
- Date terminated
- 2016-04-11
- Location
- Menlo Park, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE (K123813) | Vasonova, Inc. | 2013-01-18 |