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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Sterile Custom kits

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  Class 2 Device Recall DeRoyal Sterile Custom kits see related information
Date Initiated by Firm October 16, 2017
Create Date December 06, 2017
Recall Status1 Terminated 3 on August 21, 2020
Recall Number Z-0199-2018
Recall Event ID 78517
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads:
a) Incision and Drainage Tray, REF 47-763.04
b) Incision and Drainage Tray, REF 47-763.06
c) Incision and Drainage Tray, REF 47-763.07
d) Cricothyreotomy Ambulance Kit, REF 89-6752.01
e) Incision and Drainage Tray, REF 89-6818.02
f) Plastic Pack, REF 89-7212.04
g) Plastic Pack, REF 89-7212.05

Product Usage:
Custom surgical and procedural kits
Code Information a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact
865-938-7828
Manufacturer Reason
for Recall		 Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DeRoyal sent an Urgent Recall Notice letter dated October 17, 2017, to the end-user level. The letter identified the affected product, problem and actions to be taken. Consignees were asked to return any product they held in stock to DeRoyal and to complete the Notice of Return Form indicating what they were returning. Credit will be issued. They were asked to complete and return the Notice of Return Form even if they no longer held any affected product. For questions call 865-362-4203.
Quantity in Commerce 5946 units
Distribution US Nationwide distribution in the states of GA, IN, FL, and PA
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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