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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 Needlessee related information
Date Initiated by FirmMay 11, 2017
Create DateJune 06, 2017
Recall Status1 Terminated 3 on January 25, 2018
Recall NumberZ-2252-2017
Recall Event ID 77273
Product Classification Saw, manual and accessories - Product Code GDR
ProductClear 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 ContactRebecca 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
ActionArgon 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 Commerce7140 pieces
DistributionWorldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, 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.
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