medical Class II Updated 2020-03-11

Deroyal Industries, Inc. Lafollette recalls DeRoyal Sterile Custom Kits containing Cardinal Health Gowns

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
Lot/Code Info: Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Kwik Kit 89-6389.06, Lot number: 49624025 exp. 07/01/2023
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