Class II — Potential Health Hazard

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

Custom Dialysis Kit CF-4235 Without Gel Recalled by Merit Medical Systems, Inc. Due to 2 Cuff catheters were incorrectly configured and labeled...

Date: September 20, 2017
Company: Merit 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 Merit Medical Systems, Inc. directly.

Affected Products

Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

Quantity: 44

Why Was This Recalled?

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.

Where Was This Sold?

United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

About Merit Medical Systems, Inc.

Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.

Related Recalls

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