PlainRecalls
FDA Devices Moderate Class II 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.

Reported: June 14, 2017 Initiated: May 11, 2017 #Z-2252-2017

Product Description

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.

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.

Details

Units Affected
7140 pieces
Distribution
Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Location
Athens, TX

Frequently Asked Questions

What product was recalled?
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.. Recalled by Argon Medical Devices, Inc. Units affected: 7140 pieces.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2252-2017.