Date Initiated by Firm | June 04, 2015 |
Date Posted | June 25, 2015 |
Recall Status1 |
Terminated 3 on October 27, 2015 |
Recall Number | Z-1845-2015 |
Recall Event ID |
71537 |
510(K)Number | K111395 |
Product Classification |
Wire, guide, catheter - Product Code DQX
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Product | Prestige Plus 185cm J-Tip:
Part number: 9185J;
Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease. |
Code Information |
Product number 9185J; lot number 50004551/005-060, serial numbers 005-060. |
Recalling Firm/ Manufacturer |
Volcano Corporation 2870 Kilgore Rd Rancho Cordova CA 95670-6133
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For Additional Information Contact | Lisa Quaglia 978-439-3586 |
Manufacturer Reason for Recall | During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory. |
Quantity in Commerce | 162 total (both devices) |
Distribution | US Nationwide Distribution and one account in Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQX
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