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U.S. Department of Health and Human Services

Class 2 Device Recall Hydrophilic Wire

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 Class 2 Device Recall Hydrophilic Wiresee related information
Date Initiated by FirmFebruary 26, 2009
Date PostedMay 26, 2009
Recall Status1 Terminated 3 on January 07, 2010
Recall NumberZ-1306-2009
Recall Event ID 51284
510(K)NumberK011905 
Product Classification Wire, guide, catheter - Product Code DQX
ProductHydrophilic 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
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
ActionArgon 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 Commerce750 units
DistributionWorldwide 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 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 = DQX
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