FDA Medical Device Recalls (openFDA)
Beaver Visitec International, Inc.: Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
- Recall number
- Z-2162-2024
- Recalling firm
- Beaver Visitec International, Inc.
- Product
- Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
- Status
- Open, Classified
- Initiated
- 2024-05-10
- Posted
- 2024-06-20
- Terminated
- not on file
- Reason
- The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
- Root cause
- Process control
- Action
- An URGENT Field Safety Notice dated 5/10/24 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. In case you purchased the CustomEye Kit please be advised it is not possible to check the bevel orientation without losing the KIT sterility. In such case, immediately put the KIT out of use. 2. In case a non-conforming product is identified please quarantine it and return ALL quarantined product from the affected lots to our company via pre-paid postal labels, supplied to you with an initial notification 3. 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. 4. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession. 5. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed. 6. Return the completed BRF to BVI by emailing the attached to bvi5577@sedgwick.com (U.S based customers) or to FA-24-002XstarOUS@Sedgwick.com (rest of the world based customers). 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 00564835. Country Customer Service Email UK UKCustomerSupport@bvimedical.com FR serviceclient@bvimedical.com DE/ AT Kundendienst@bvimedical.com IT servizioclienti@bvimedical.com ROW ROWCustomerSupport@bvimedical
- Quantity
- 126 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
- Lot, serial or model codes
- Xstar Safety Slit Knife: UDI-DI: 00886158001652; Lot Number: 6058854; CustomEye Kit # 584562 , lot # 6068524; CustomEye Kit # 584562 , lot # 6068025; CustomEye Kit # 5800109, lot # 6068285
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNN
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28