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U.S. Department of Health and Human Services

Class 2 Device Recall CRANI PACK

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  Class 2 Device Recall CRANI PACK see related information
Date Initiated by Firm June 18, 2019
Create Date July 16, 2019
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-1981-2019
Recall Event ID 83154
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07

custom surgical pack
Code Information Lot 49888830
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		 Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, DeRoyal, initiated the recall by "URGENT! RECALL NOTICE" letter and email on 06/18/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Using the attached Affected Products Listing, identify affected part/lot numbers in your inventory and place in quarantine to prevent further use. Please complete the Notice of Return Form and return the part/lot numbers that you have in inventory to us. You will be given credit or replacement for the returned product, whichever you prefer. 2) Complete the Affected Products Listing spreadsheet, indicating all affected products found in your inventory. PLEASE COMPLETE THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 3) Please return the completed Affected Products Listing spreadsheet and the Notice of Return Form to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than July 22, 2019. 4) If you have further distributed these products, your customers must notified of this recall. You may either do this directly or notify us that you have done so, or you may provide us with your customer listing and we will contact them. 5) If you have questions or need assistance with the recall, please email: jmarsh@deroyal.com or call 865-362-4203 or email us at recalls@deroyal.com.
Quantity in Commerce 108 units
Distribution US Distribution to: OK
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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