Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Safedraw Venous Close Loop System Recalled by Argon Medical Devices, Inc Due to Some of the kits may exhibit a potential...

Date: May 4, 2012
Company: Argon Medical Devices, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Argon Medical Devices, Inc directly.

Affected Products

Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.

Quantity: 10 pieces

Why Was This Recalled?

Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.

Where Was This Sold?

Distributed only in Missouri.

About Argon Medical Devices, Inc

Argon Medical Devices, Inc has 42 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report