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Recall Observatory FDA recall evidence

Device product

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

Z-2162-2024

May 10, 2024

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 94645
Status
Ongoing
Classification
Class II
Quantity
126 units
Official record key
device-enforcement:Z-2162-2024

Official wording

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).

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).