—#155591

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.

FDA product code: GDR — Saw, Manual And Accessories
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 11161099 11161729 11160990 11160912

Why it was 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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

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

Timeline

Recall initiated: 2017-05-11
Terminated: 2018-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155591. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.