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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 04, 2020
Date PostedFebruary 19, 2020
Recall Status1 Terminated 3 on April 01, 2021
Recall NumberZ-1411-2020
Recall Event ID 84889
510(K)NumberK842648 
Product Classification General surgery tray - Product Code LRO
ProductDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Code Information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ;  Chronic Ear Pack 89-4393.17, Lot number: 49241024 exp. 07/01/2020;  
Recalling Firm/
Manufacturer		 Deroyal Industries, Inc. Lafollette
1501 E Central Ave
La Follette TN 37766-2892
For Additional Information ContactTheresa 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 2		Environmental control
ActionDeRoyal 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 Commerce2100 units
DistributionUS: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LRO
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