CLASS II Device recall · Reported 13 Apr 2022 · FDA Enforcement Report

DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic recalled

DeRoyal Industries is recalling DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and, distributed in Florida, New Jersey, Tennessee. The recall was initiated on 3 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSKU/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)

Quantity recalled780 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0879-2022
FDA event ID: 89737
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Terminated
Recall initiated: 3 Mar 2022
FDA classified: 6 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Mar 2022	Recall initiated by company
6 Apr 2022	Classified by FDA	+34 days
13 Apr 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Product as listed by the FDA

DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

Where it was distributed

US distribution to Florida, New Jersey, and Tennessee

Florida New Jersey Tennessee

Questions about this recall

Is DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and recalled?

Yes. DeRoyal Industries recalled DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and on 3 Mar 2022. The recall is Class II and its status is Terminated. Recall number Z-0879-2022.

Why was it recalled?

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Which lots are affected?

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)

Where was it sold?

US distribution to Florida, New Jersey, and Tennessee

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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