| Class 1 Device Recall HydroFinity Guidewire | |
Date Initiated by Firm | May 28, 2014 |
Date Posted | June 25, 2014 |
Recall Status1 |
Terminated 3 on January 13, 2015 |
Recall Number | Z-1817-2014 |
Recall Event ID |
68419 |
510(K)Number | K121398 |
Product Classification |
Wire, guide, catheter - Product Code DQX
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Product | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Straight Tip, 260 CM Length
Manufactured for Covidien, Plymouth, MN;
Manufactured by: NDC Inc., Fremont, CA.
Manufactured in Costa Rica
The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures. |
Code Information |
Model HPRS35260- all lots. |
Recalling Firm/ Manufacturer |
Nitinol Devices and Components, Inc. 47533 Westinghouse Dr Fremont CA 94539-7463
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For Additional Information Contact | Mark A. Turco 202-310-5120 |
Manufacturer Reason for Recall | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
FDA Determined Cause 2 | Device Design |
Action | Covidien sent an Urgent Product Recall letter dated May 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused devices to Covidien, their account would be credited. Customers were also instructed to::
1) Stop using product listed in this letter immediately
2) Segregate this product from other inventory
3) Fill out the reply (verification) form at the end of this letter
If you do not have any product identified in this letter, please fax or
email the completed form to Covidien at (877) 523-9109 or
covidien8770@stericycle.com.
If you do have product, your sales representative will assist you in
completing the verification form and arranging for return of the
product.
Please fax the completed form to Covidien (877) 523-9109 or email to
covidien8770@stericycle.com.
4) Your sales representative will be available to answer any questions regarding this recall and assist you in completing the verification form, returning product and addressing any account credits.
This action is being conducted with the knowledge of the United States FDA and other regulatory authorities. Customers with questions were instructed to call (202) 310-5120.
For questions regarding this recall call 202-310-5120.
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Quantity in Commerce | 8485 in US, 9595 - ROW - total, all models |
Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and 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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