DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics… recallZ-0880-2022 · 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-0880-2022
- Status
- Terminated
- Initiated by the company
- Mar 3, 2022
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 1360 kits
- Product code
- LRO
- FDA submissions
- K842648
- Distribution
- US distribution to Florida, New Jersey, and Tennessee
Product description
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 (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-5300Deroyal 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-0879-2022 · TerminatedDeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
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.
How recalls are matched to devices · Editorial policy · Report an error on this page