| Class 2 Device Recall Hydrophilic Wire | |
Date Initiated by Firm | February 26, 2009 |
Date Posted | May 26, 2009 |
Recall Status1 |
Terminated 3 on January 07, 2010 |
Recall Number | Z-1306-2009 |
Recall Event ID |
51284 |
510(K)Number | K011905 |
Product Classification |
Wire, guide, catheter - Product Code DQX
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Product | Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Total Vein Solutions, 901 Yale Street - Houston, Texas 77008, (713) 863-1600 Fax 713 863-1601, www.totalvein.com. |
Code Information |
All lot codes. |
Recalling Firm/ Manufacturer |
Argon Medical Devices, Inc 1445 Flat Creek Rd Athens TX 75751
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For Additional Information Contact | 903-675-9321 |
Manufacturer Reason for Recall | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
FDA Determined Cause 2 | Other |
Action | Argon Medical Devices Inc. issued an "Urgent Field Safety Notice" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396).
For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319. |
Quantity in Commerce | 750 units |
Distribution | Worldwide Distribution -- US including Puerto Rico and states of AL, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, MT, NC, NJ, NV, NY, PA, SC, TN, TX, UT, VA and WI and countries of Germany, Thailand, Turkey and the Netherlands. |
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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