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U.S. Department of Health and Human Services

Class 2 Device Recall Argoguide Hydrophilic Wire

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  Class 2 Device Recall Argoguide Hydrophilic Wire see related information
Date Initiated by Firm February 26, 2009
Date Posted May 26, 2009
Recall Status1 Terminated 3 on January 07, 2010
Recall Number Z-1302-2009
Recall Event ID 51284
510(K)Number K011905  
Product Classification Wire, guide, catheter - Product Code DQX
Product Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387322, .038/150 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.
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
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 130 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
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) Database 510(K)s with Product Code = DQX and Original Applicant = MAXXIM MEDICAL
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