FDAClass IIJune 14, 2017

Clear Flashback Needle 7cm x recall

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…

Why was Clear Flashback Needle 7cm x 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

11161099 11161729 11160990 11160912

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…
Recalling firm
Argon Medical Devices, Inc
Quantity
7140 pieces
Distribution
Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Recall date
June 14, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls