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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 04, 2020
Date Posted February 19, 2020
Recall Status1 Terminated 3 on April 01, 2021
Recall Number Z-1414-2020
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:

Cystoscopy Pack 89-6071.15
Code Information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ;  Cystoscopy Pack 89-6071.15, Lot number: 49442168 exp 03/01/2021;  
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 2		 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 and Original Applicant = DEROYAL INDUSTRIES, INC.
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