Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and ster...
FDA Device Recall #Z-1468-2023 — Class II — February 20, 2023
Recall Summary
| Recall Number | Z-1468-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 20, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mani, Inc. - Kiyohara Facility |
| Location | Utsunomiya, N/A |
| Product Type | Devices |
| Quantity | 45 kits |
Product Description
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.
Reason for Recall
A packaging defect may compromise the sterile barrier.
Distribution Pattern
Distribution in US - 1 consignee in Missouri
Lot / Code Information
UDI-DI: 14546951403956 (Model MTK25S) Mani Trocar Kit: 1) Model MTK23S, Lot V210028903 (exp. 2024-03) 2) Model MTK25S, Lot V210009900 (exp. 2023-03) 3) Model MTK25S, Lot V210006701 (exp. 2023-04) 4) Model MTK25S, Lot V210009101 (exp. 2023-11) 5) Model MTK25S, Lot V220016001 (exp. 2024-11-08)
Other Recalls from Mani, Inc. - Kiyohara Facility
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0558-2021 | Class II | MANI Infusion Cannula 23G S - Product Usage: fo... | Oct 27, 2020 |
| Z-0557-2021 | Class II | MANI TROCAR KIT 23G S - Product Usage: for use ... | Oct 27, 2020 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.