FDA-Device2019-01-30Class II

Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

Stihler Electronic Gmbh
Hazard

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

Sold states
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Affected count
1 unit
Manufactured in
Julius-Holder-Str. 36, N/A, Stuttgart, N/A, Germany
Products
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0760-2019

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