Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall DeRoyal see related information
Date Initiated by Firm March 03, 2022
Create Date April 06, 2022
Recall Status1 Terminated 3 on September 15, 2022
Recall Number Z-0880-2022
Recall Event ID 89737
510(K)Number K842648  
Product Classification General surgery tray - Product Code LRO
Product DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Code Information SKU/Part Number 89-5300.07; UDI 00749756632317  Lot Numbers (Expiration Date): Lot 53059743 (exp 06/01/2022), Lot 53632941 (exp 06/01/2022), Lot 53666113 (exp 06/01/2022), Lot 54205909 (exp 06/01/2022), Lot 54279422 (exp 06/01/2022), Lot 54327332 (exp 06/01/2022), Lot 54473313 (exp 06/01/2022), Lot 55573404 (exp 06/01/2022)
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		 A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
FDA Determined
Cause 2		 Process control
Action DeRoyal issued their recall on March 3, 2022 to the end user level by mailing 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 product and the notice of return form that was provided back to DeRoyal.
Quantity in Commerce 1360 kits
Distribution US distribution to Florida, New Jersey, and Tennessee
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.
-
-