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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LRO
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