Deroyal Industries, Inc. Lafollette: Medical Device Recall in 2020 - (Recall #: Z-1412-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08

Product Classification:

Class II

Date Initiated: February 4, 2020

Date Posted: March 11, 2020

Recall Number: Z-1412-2020

Event ID: 84889

Reason for Recall:

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

Status: Terminated

Product Quantity: 2100 units

Code Information:

Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Shoulder Pack 89-4751.08, Lot number: 49505405 exp. 11/01/2021

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated