Reported May 3, 2023 · Terminated
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3…
Mani, Inc. - Kiyohara Facility
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mani, Inc. - Kiyohara Facility · Park 8-3 · Utsunomiya, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published MTK23SLot V210028903 (exp. 2024-03) MTK25SLot V210009900 (exp. 2023-03) MTK25SLot V210006701 (exp. 2023-04) MTK25SLot V210009101 (exp. 2023-11) MTK25SLot V220016001 (exp. 2024-11-08) - Amount recalled
- 45 kits
Where it was sold
Why it was recalled
A packaging defect may compromise the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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