Class II

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

Beaver Visitec International, Inc. · May 10, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

126 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2162-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Beaver Visitec International, Inc. Medical Device Recall: Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109 | SafeCheck