Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pc
FDA device recall Z-1468-2023 · posted 2023-04-26 · Terminated
Recall details
- Recalling firm
- Mani, Inc. - Kiyohara Facility
- Reason for recall
- A packaging defect may compromise the sterile barrier.
- Action taken
- Notification to the impacted consignee was made by letter on 03/01/2023. Consignee(s) are to examine inventory and quarantine any affected product. Notification of the recall must be forwarded to any other impacted entities. Consignee(s) are to complete and return the Acknowledgement and Receipt form to the recalling firm.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NGY
- Quantity affected
- 45 kits
- Distribution
- Distribution in US - 1 consignee in Missouri
- Date initiated
- 2023-02-20
- Date posted
- 2023-04-26
- Date terminated
- 2025-05-19
- Location
- Utsunomiya, Japan
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.