Class II — Potential Health Hazard

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

AMS-651 Recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Due to Incorrect priming volume is printed on the device...

Date: November 18, 2016
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

AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

Quantity: 31,500

Why Was This Recalled?

Incorrect priming volume is printed on the device package.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

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