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: ASC Laparoscopy Pack 89-6138.13


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; f. ASC Laparoscopy Pack 89-6138.13, Lot number: 49505093 exp.10/01/2023;
View official government recall

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