Z-0879-2022Class II

DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol)...

Name: Z-0879-2022 DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol)...
Creator: DeRoyal Industries Inc
Published: 2022-03-03
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2022-03-03 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to... on 2022-03-03. FDA classified it as Class II and gives the reason as "A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0879-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-03
Posted: 2022-04-06
Terminated: 2022-09-15
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Product code: LRO General Surgery Tray
Reason for recall: A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Root cause tag: manufacturing process
FDA root cause: 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: 780 kits
Distribution: US distribution to Florida, New Jersey, and Tennessee
Product codes and lots: SKU/Part Number 89-4990.06; UDI 00749756623599 Lot Numbers (Expiration Date): Lot 53334442 (exp 05/01/2021), Lot 53815781 (exp 06/01/2022), Lot 54685720 (exp 06/01/2022), Lot 55247529 (exp 03/01/2023), Lot 55967067 (exp 04/01/2023)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0879-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0878-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-06
Z-0879-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-06
Z-0880-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-06

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)