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Terminated

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.

FDA Recall Z-2252-2017 · Posted None

Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeGDR
Date Initiated2017-05-11
Date Terminated2018-01-25
Product Quantity7140 pieces

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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