Stihler Electronic Gmbh recalls Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO I…

Recall date

September 6, 2018

Source

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

Recall number

Z-0761-2019

FDA classification

Class II

Brand / firm

Stihler Electronic Gmbh

Sold / distributed

Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland

Why it was recalled

PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn

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

What was recalled

Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.