Drug recall
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit…
FDA recall event 91829 · Class II · Mani, Inc. - Kiyohara Facility
Key facts
| Event ID | 91829 |
|---|---|
| Recall numbers | Z-1468-2023 |
| Recalling firm | Mani, Inc. - Kiyohara Facility |
| Product type | Devices |
| Products | Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A packaging defect may compromise the sterile barrier. |
| Initiation date | Feb 20, 2023 |
| Report date | May 3, 2023 |
| Termination date | May 19, 2025 |
| City | Utsunomiya |
| Country | Japan |
| FEI number | 3002692886 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: