Class II — Potential Health Hazard

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

Vygon IV Start Convenience Kits Recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Due to The Iodine Prep Pads within the Vygon IV...

Date: October 3, 2017
Company: Vygon MFG, Inc., dba/ Churchill Medical Systems, 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 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. directly.

Affected Products

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

Quantity: 21350

Why Was This Recalled?

The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.

Where Was This Sold?

US Distribution.

About Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. has 9 total recalls tracked by RecallDetector.

Related Recalls

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