Class II — Potential Health Hazard

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

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as Recalled by Deroyal Industries, Inc. Lafollette Due to Cardinal Health gowns contain an unknown level of...

Date: February 4, 2020
Company: Deroyal Industries, Inc. Lafollette
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 Deroyal Industries, Inc. Lafollette directly.

Affected Products

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06

Quantity: 2100 units

Why Was This Recalled?

Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Where Was This Sold?

US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange

About Deroyal Industries, Inc. Lafollette

Deroyal Industries, Inc. Lafollette has 12 total recalls tracked by RecallDetector.

Related Recalls

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