Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Monoject 0.9% Sodium Chloride Recalled by Windstone Medical Packaging, Inc. Due to Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by...

Date: August 19, 2021
Company: Windstone Medical Packaging, Inc.
Status: Ongoing
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 Windstone Medical Packaging, Inc. directly.

Affected Products

Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack

Quantity: 9,378

Why Was This Recalled?

Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.

Where Was This Sold?

This product was distributed to 2 states: FL, PA

Affected (2 states)Not affected

About Windstone Medical Packaging, Inc.

Windstone Medical Packaging, Inc. has 315 total recalls tracked by RecallDetector.

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