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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 November 19, 2007
Date Posted January 31, 2008
Recall Status1 Terminated 3 on June 05, 2008
Recall Number Z-0886-2008
Recall Event ID 45857
510(K)Number K011905  
Product Classification Catheter guide wire - Product Code DQX
Product Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
Code Information Lot Numbers: 99504912, 99509169, and 99534483
Recalling Firm/
Manufacturer
Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact
903-675-9321
Manufacturer Reason
for Recall
Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
FDA Determined
Cause 2
Process design
Action Argon Medical sent an Urgent Product Recall letter to consignees on 11/15/2007. They requested that users immediately quarantine and return any product remaining at their facility, utilizing instruction on response card. Distributors were directed to issue the recall to their customers and return all retrieved product to Argon.
Quantity in Commerce 1,014
Distribution Worldwide Distribution -- USA including states of FL, KS, NV, IL, CA, NY, CO, VA, MD, NC, UT, GA, MI, NJ, TN, MA, and CT, and countries of The Netherlands, Germany, and Turkey.
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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