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Recall Observatory FDA recall evidence

Device 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.

Z-1468-2023

February 20, 2023

Class II

Product summary

Firm
Mani, Inc. - Kiyohara Facility
Event
Event 91829
Status
Terminated
Classification
Class II
Quantity
45 kits
Official record key
device-enforcement:Z-1468-2023

Official wording

Reason: A packaging defect may compromise the sterile barrier.

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)

Distribution pattern: Distribution in US - 1 consignee in Missouri

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging defect
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging defect may compromise the sterile