Beaver Xstar Slit Knife 2 recalled over labeling errors

Recall date

March 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Beaver Visitec recalls Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 37…

Recall number

Z-1111-2019

FDA classification

Class II

Brand / firm

Beaver Visitec

Sold / distributed

Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS

Why it was recalled

Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures