Argon Medical Devices, Inc: Medical Device Recall in 2017 - (Recall #: Z-2252-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 11, 2017

Date Posted: June 14, 2017

Recall Number: Z-2252-2017

Event ID: 77273

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.

Status: Terminated

Product Quantity: 7140 pieces

Code Information:

11161099 11161729 11160990 11160912

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated