Medical device recalls Moderate risk

Beaver-Visitec International Inc. recalls WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot o…

Recall date
February 26, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1539-2018
FDA classification
Class II
Brand / firm
Beaver-Visitec International Inc.
Sold / distributed
Distributed to the states of OH, NY, FL, MN, and KS.

Why it was recalled

Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.

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

What was recalled

WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.

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