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Recall Observatory FDA recall evidence

Device product

Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025

Z-0633-2024

October 10, 2023

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 93555
Status
Ongoing
Classification
Class II
Quantity
2160 units
Official record key
device-enforcement:Z-0633-2024

Official wording

Reason: 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.

Code information: UDI-DI: 30886158000373; Lot Number: 6049877

Distribution pattern: International Distribution to Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.