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 Healthcare Systems Recalled by Custom Healthcare Systems, Inc. Due to A component (1961 TELFA PAD 2 X 3)...

Date: December 20, 2019
Company: Custom Healthcare 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 Custom Healthcare Systems, Inc. directly.

Affected Products

Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

Quantity: 240 kits

Why Was This Recalled?

A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

About Custom Healthcare Systems, Inc.

Custom Healthcare Systems, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

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