FDA Device recall Z-1542-2021
Regard Dressing Change Tray
- FDA Device
- Class II
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of Regard Dressing Change Tray by Roi Cps, citing chloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1542-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-26 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard Dressing Change Tray
Reason
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Identifiers
| code_info | Lot Numbers: 86983C, 87081C and 86356C. |
|---|
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-1542-2021%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.