Medical device recalls Moderate risk

Thermo Fisher Scientific (Asheville) LLC recalls Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05

Recall date
April 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1865-2019
FDA classification
Class II
Brand / firm
Thermo Fisher Scientific (Asheville) LLC
Sold / distributed
CA, GA, KY, PA Foreign: Canada, China, Germany, Japan, New Zealand, Australia

Why it was recalled

Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.

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

What was recalled

Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05

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