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Recall Observatory FDA recall evidence

Device 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 x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

Z-2252-2017

May 11, 2017

Class II

Product summary

Firm
Argon Medical Devices, Inc
Event
Event 77273
Status
Terminated
Classification
Class II
Quantity
7140 pieces
Official record key
device-enforcement:Z-2252-2017

Official wording

Reason: 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.

Code information: 11161099 11161729 11160990 11160912

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging defect