Medical device recalls Moderate risk

Slit Knife 2 recalled over labeling errors

Recall date
June 18, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Beaver Visitec recalls Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Recall number
Z-2740-2018
FDA classification
Class II
Brand / firm
Beaver Visitec
Sold / distributed
Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel

Why it was recalled

Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.

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

What was recalled

Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

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