FDA Enforcement Class II Ongoing

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

Recall: Z-0633-2024 · Reported January 10, 2024

Enforcement

Recall Number
Z-0633-2024
Event ID
93555
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Beaver Visitec International, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
January 10, 2024
Initiation Date
October 10, 2023
Classification Date
January 4, 2024
Address
500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

Description

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

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 Info

UDI-DI: 30886158000373; Lot Number: 6049877

Distribution

International Distribution to Japan.

Quantity

2160 units