Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility
Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves surgical instruments with a risk-of-harm defect affecting sterility. No illnesses or injuries have been reported. As an FDA Class II recall without reported harm, this meets the criteria for High severity per the rubric.
Plain-English summary
Mani Trocar Kit Models MTK23S and MTK25S are subject to a recall issued by the U.S. Food and Drug Administration. These are sterile surgical kits containing three trocars with valved cannulas and one infusion cannula per kit, used in laparoscopic surgical procedures.
The recall is due to a packaging defect that may compromise the sterile barrier of the product. A total of 45 kits were affected and distributed to one consignee in Missouri.
The recalled lots include: Model MTK23S Lot V210028903 (expiration 2024-03), and Model MTK25S Lots V210009900 (expiration 2023-03), V210006701 (expiration 2023-04), V210009101 (expiration 2023-11), and V220016001 (expiration 2024-11-08).
Affected healthcare facilities should cease use of these kits and contact the manufacturer, Mani Inc., for return and replacement procedures.
The recalled product
- Product
- 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.
- Manufacturer
- Mani, Inc. - Kiyohara Facility
- Hazard
- packaging-defect
- sterile-barrier-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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)
Distribution
Distribution scope not specified by the agency.
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