FDA Device recall Z-0879-2022
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the pat…
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the pat… by Deroyal Industries, citing A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0879-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-03 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | FL, NJ, TN |
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.
Reason
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Identifiers
| code_info | SKU/Part Number 89-4990.06; UDI 00749756623599 Lot Numbers (Expiration Date): Lot 53334442 (exp 05/01/2021), Lot 538…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0879-2022%22
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