Medical device recalls Moderate risk

BOND Slide Labeler Zebra Printer and recalled over fire hazard

Recall date
September 17, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Leica Microsystems, Inc. recalls BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Recall number
Z-0281-2019
FDA classification
Class II
Brand / firm
Leica Microsystems, Inc.
Sold / distributed
Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.

Why it was recalled

The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.

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

What was recalled

BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments

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