FDA-Device2017-06-14Class II
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.
Argon Medical Devices, Inc
Hazard
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.
Sold states
Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Affected count
7140 pieces
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2252-2017Don't want to check this manually?
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