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U.S. Department of Health and Human Services

Class 2 Device Recall MicroStic Plus

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  Class 2 Device Recall MicroStic Plus see related information
Date Initiated by Firm September 08, 2016
Date Posted October 07, 2016
Recall Status1 Terminated 3 on June 07, 2017
Recall Number Z-0051-2017
Recall Event ID 75213
510(K)Number K071574  
Product Classification Introducer, catheter - Product Code DYB
Product MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F.

A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Code Information 11149662, 11151447, 11151617, and 11149822.
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
Manufacturer Reason
for Recall		 The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent - Product Recall Notice was sent to consignees identifying the affected device and the reason for the recall. Customers were asked to return all affected devices. The firm will send replacement devices upon receipt of the returned affected product and once assembly of a cleared lot that does not contain recalled devices has been completed. If there are questions regarding the letter or recall action, customers can contact Beckie.Ellis@argonmedical.com.
Quantity in Commerce 200 units
Distribution Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
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 = DYB and Original Applicant = ENPATH MEDICAL, INC.
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