Class 2 Device Recall

• Date Initiated by Firm: February 04, 2020
• Date Posted: February 19, 2020
• Recall Status: Terminated on April 01, 2021
• Recall Number: Z-1413-2020
• Recall Event ID: 84889
• 510(K)Number: K842648
• Product Classification: General surgery tray - Product Code LRO
• Product: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
• Code Information: Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC General Pack 89-6015.16, Lot Numbers: 49215900 exp. 06/01/2023, 49266256 exp. 06/01/2023
• Recalling Firm/ Manufacturer: Deroyal Industries, Inc. Lafollette; 1501 E Central Ave; La Follette TN 37766-2892
• For Additional Information Contact: Theresa Marsee; 865-362-6465
• Manufacturer Reason for Recall: Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
• FDA Determined Cause: Environmental control
• Action: DeRoyal issued their recall on 1/26/2020 to the end user level by sending recall letters to its direct accounts. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested.
• Quantity in Commerce: 2100 units
• Distribution: US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LRO