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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow VPS Vascular Positioning System Console and Stylet Extension Cable

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 Class 2 Device Recall Arrow VPS Vascular Positioning System Console and Stylet Extension Cablesee related information
Date Initiated by FirmMarch 30, 2015
Date PostedApril 09, 2015
Recall Status1 Terminated 3 on April 11, 2016
Recall NumberZ-1408-2015
Recall Event ID 70927
510(K)NumberK123813 
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
ProductVasoNova 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.
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 
Recalling Firm/
Manufacturer		 VasoNova, Inc.
155 Jefferson Dr
Menlo Park CA 94025-1114
For Additional Information ContactKaren Boylan
650-388-5600
Manufacturer 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 2		Device Design
ActionTeleflex 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 in Commerce17
DistributionUS Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OBJ
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