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U.S. Department of Health and Human Services

Class 2 Device Recall Deroyal

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  Class 2 Device Recall Deroyal see related information
Date Initiated by Firm May 30, 2023
Date Posted July 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-2086-2023
Recall Event ID 92445
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product Custom medical procedure packs labeled as:

a) OPEN HEART TRACECART, REF '53-1941;
b) CARDIAC CATH PACK, REF '89-10045;
c) SHOULDER PACK, REF '89-10115;
d) MINOR ORTHO PACK, REF '89-10213;
e) TOTAL KNEE PACK PGYBK, REF '89-10505;
f) ANTERIOR HIP PACK PGYBK, REF '89-10563;
g) ORTHO X-RAY PACK, REF '89-1495;
h) GU PACK, REF '89-4479;
i) BREAST PACK, REF '89-5424;
j) SHOULDER ARTHROSCOPY PK, REF '89-6606;
k) GYN PACK, REF '89-7369;
l) ENT PACK, REF '89-7378;
m) TOTAL HIP PACK PGYBK, REF '89-7540;
n) EPIDURAL TRAY/CUSTOM, REF '89-8061;
o) BREAST BIOPSY TRAY, REF '89-8187;
p) BEACH CHAIR PACK, REF '89-8439;
q) TOTAL KNEE PACK PGYBK, REF '89-8445;
r) CYSTO PACK, REF '89-8482;
s) SINGLE BASIN PLUS, REF '89-9131;
t) TOTAL HIP PACK, REF '89-9287;
u) ARTHROSCOPY PACK, REF '89-9626;
v) SHOULDER PACK, REF '89-9632
CYSTO PACK, REF '89-10049
BEACH CHAIR SHOULDER PACK, REF '89-10721
EXTREMITY PACK, REF '89-10959
HYSTEROSCOPY PACK, REF '89-10960
VERITHENA VENOUS ABLATION PACK, REF '89-10977
CYSTO BASIN SET, REF '89-2577
OPEN HEART PACK, REF '89-8572
BACK PACK, REF '89-9292
Code Information a) REF '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers: 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383; b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers: 58714313; c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128 (unit), Lot Numbers: 58746278; d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers: 58745371; e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers: 58774885, 58774885; f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers: 58800174; g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers: 58762104; h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers: 58810330; i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit)

Lot Numbers: 58698974; j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit)

Lot Numbers: 58698907; k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit)

Lot Numbers: 58777761; l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit)

Lot Numbers: 58811834; m) REF '89-7540, GTIN 50749756741410 (cs), 00749756741415 (unit), Lot Numbers: 58737081; n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers: 58698042; o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers: 58736862; p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Numbers: 58823595; q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit)

Lot Numbers: 58697963; r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers: 58789411; s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit)

Lot Numbers: 58808416; t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit)

Lot Numbers 58789260; u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit)

Lot Numbers: 58738315 v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit)

Lot Numbers: 58701598
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Theresa Marsee
865-632-6465
Manufacturer Reason
for Recall		 The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
FDA Determined
Cause 2		 Process control
Action DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.
Quantity in Commerce 4225 packs
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LRO and Original Applicant = DEROYAL INDUSTRIES, INC.
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