FDA Device recall Z-0880-2022
DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation o…
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation o… 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-0880-2022 |
| 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 DEXMED ACCESS CENTER 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 89-5300.07; UDI 00749756632317 Lot Numbers (Expiration Date): Lot 53059743 (exp 06/01/2022), Lot 536…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) |
|---|
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-0880-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.