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U.S. Department of Health and Human Services

Class 2 Device Recall CV Basin Procedure Pack

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  Class 2 Device Recall CV Basin Procedure Pack see related information
Date Initiated by Firm January 25, 2021
Create Date February 19, 2021
Recall Status1 Terminated 3 on July 21, 2022
Recall Number Z-1139-2021
Recall Event ID 87218
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product Open Heart Pack, REF numbers:
a) 89-7483.07
b) 89-7483.08
c) 89-7483.09
d) 89-7483.10

Custom surgical procedure packs including sternum saw blades.
Code Information a) 89-7483.07, Lot Numbers: 48535952 exp 3/1/2021, 48613789 exp 3/1/2021, 49330297 exp 7/1/2021, 49529669 exp 8/1/2021, 49852263 exp 9/1/2021 b) 89-7483.08, Lot Numbers: 50033361 exp 11/1/2021, 50404628 exp 12/1/2021, 50783200 exp 12/1/2021 c) 89-7483.09, Lot Numbers: 51021872 exp 12/1/2021, 51121460 exp 4/1/2022, 51284373 exp 4/30/2022, 51458898 exp 4/1/2022, 51701317 exp 7/1/2022  d) 89-7483.10, Lot Numbers: 51954402 exp 9/1/2022, 52183224 exp 9/1/2022, 52413069 exp 10/1/2022, 53117579 exp 10/1/2022, 53311005 exp 11/1/2022   
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		 Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
FDA Determined
Cause 2		 Process control
Action DeRoyal issued their recall on 01/25/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal.
Quantity in Commerce 1084 packs
Distribution Distributors in OK, MI, and TX.
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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