DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic… recallZ-0879-2022 · DeRoyal Industries Inc · initiated Mar 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0879-2022
- Status
- Terminated
- Initiated by the company
- Mar 3, 2022
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 780 kits
- Product code
- LRO
- FDA submissions
- K842648
- Distribution
- US distribution to Florida, New Jersey, and Tennessee
Product description
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Code information (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-4990Deroyal Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 89737).
- Z-0878-2022 · TerminatedDeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery…
- Z-0880-2022 · TerminatedDeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or in…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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