Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3
Summary
The FDA issued a Class II for Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in by Mani, Inc. - Kiyohara Facility. Reason: A packaging defect may compromise the sterile barrier..
Details
Source
Device Recall
External ID
Z-1468-2023
Action Date
2023-05-03
Status
Terminated
Category
device
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.
Lot/Code Info: 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)
Quantity Affected: 45 kits
Reason for Recall
A packaging defect may compromise the sterile barrier.
Distribution
Distribution in US - 1 consignee in Missouri
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-20
Company
Utsunomiya, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mani, Inc. - Kiyohara Facility) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mani, Inc. - Kiyohara Facility have FDA actions?
This is the only FDA action we have on record for Mani, Inc. - Kiyohara Facility in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1468-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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