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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal (R) CYSTO TRAY

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  Class 2 Device Recall DeRoyal (R) CYSTO TRAY see related information
Date Initiated by Firm August 11, 2016
Date Posted August 26, 2016
Recall Status1 Terminated 3 on June 13, 2017
Recall Number Z-2679-2016
Recall Event ID 74927
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Code Information Lot Number 40004006
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Theresa Marsee
865-362-6465
Manufacturer Reason
for Recall		 The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.
Quantity in Commerce 24 units
Distribution Distributed in LA and TN.
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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