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.
Reported: May 3, 2023 Initiated: February 20, 2023 #Z-1468-2023
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.
Details
- Recalling Firm
- Mani, Inc. - Kiyohara Facility
- Units Affected
- 45 kits
- Distribution
- Distribution in US - 1 consignee in Missouri
- Location
- Utsunomiya, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mani, Inc. - Kiyohara Facility. Units affected: 45 kits.
Why was this product recalled? ▼
A packaging defect may compromise the sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2023. Severity: Moderate. Recall number: Z-1468-2023.
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