Z-2162-2024Class II

Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers...

Name: Z-2162-2024 Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers...
Creator: Beaver Visitec International, Inc.
Published: 2024-05-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-05-10 / Open, Classified / root cause: manufacturing process

FDA source

Beaver Visitec International, Inc. began a recall of Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109 on 2024-05-10. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2162-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-10
Posted: 2024-06-20
Recalling firm: Becton Dickinson & Co
Product: Xstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
Product code: HNN Knife, Ophthalmic
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] (U.S based customers) or to [email protected] (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 [email protected] FR [email protected] DE/ AT [email protected] IT [email protected] ROW ROWCustomerSupport@bvimedical
Quantity in commerce: 126 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2162-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2161-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-20
Z-2162-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-20

Product code HNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)