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FDAFDA · Food and drugs·Recall number Z-2162-2024

Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109

Published June 26, 2024 · Recall initiated: May 10, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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).

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Beaver Visitec International, Inc.
Distributor
Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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