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U.S. Department of Health and Human Services

Class 2 Device Recall Arterial Needles

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  Class 2 Device Recall Arterial Needles see related information
Date Initiated by Firm May 11, 2017
Create Date June 06, 2017
Recall Status1 Terminated 3 on January 25, 2018
Recall Number Z-2252-2017
Recall Event ID 77273
Product Classification Saw, manual and accessories - Product Code GDR
Product Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4

Usage:
Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
Code Information 11161099 11161729 11160990 11160912 
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact Rebecca Ellis
972-403-0749
Manufacturer Reason
for Recall		 Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
FDA Determined
Cause 2		 Process design
Action Argon Medical Devices, Inc. is sending an Urgent Medical Device Recall letter by registered mail to the affected customer/hospital/distributor. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form.
Quantity in Commerce 7140 pieces
Distribution Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, 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.
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