FDA Device recall Z-2685-2024
Regard Kit containing the Microtek decanter
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Regard Kit containing the Microtek decanter by Roi Cps, citing decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2685-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-17 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard Kit containing the Microtek decanter
Reason
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Identifiers
| code_info | Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Roi Cps
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
FDA Device · Class I · 2025-02-12 · Roi Cps - regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Device · Class II · 2024-09-25 · Roi Cps - regard Operative LAP, Item Number 800943001
FDA Device · Class I · 2024-01-24 · Roi Cps - Regard Dressing change kit, Item Number 800026006
FDA Device · Class I · 2024-01-10 · Roi Cps - Regard CV PK, Item Numbers a) 880289014, b) 880289015
FDA Device · Class II · 2023-11-22 · Roi Cps
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2685-2024%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.