Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part… recallZ-0633-2024 · Beaver Visitec International, Inc. · initiated Oct 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beaver Visitec International, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
FDA root cause category: Under Investigation by firm
What the company is doing
An "URGENT Field Safety Notice" dated 10/10/23 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. Only destroy the knives in your inventory that have the incorrect bevel orientation (bevel down). If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed. 4. Return the completed BRF and evidence of destruction of affected product to BVI by emailing the attached to [email protected]. BVI values your business and apologizes for the inconvenience this may have caused. Please direct any questions regarding credit to our customer service department by email and include in the subject line: Master Case PIR 00487979. Country Customer Service Email UK [email protected] FR [email protected] DE/ AT [email protected] IT [email protected] ROW [email protected]
Recall details
- Recall number
- Z-0633-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 10, 2023
- Posted by the FDA
- Jan 4, 2024
- Recalling firm
- Beaver Visitec International, Inc.
- Quantity
- 2160 units
- Product code
- HNN
- Distribution
- International Distribution to Japan.
Product description
Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025
Code information (models, lots, serial numbers)
UDI-DI: 30886158000373; Lot Number: 6049877
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Beaver® 373025Beaver-Visitec International, Inc. · Knife, ophthalmic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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