FDA recall Z-2162-2024

Beaver Visitec International, Inc. · Class II · device

Product

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

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).

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2024-05-10
Report date: 2024-06-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2024