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Stihler Electronic Gmbh recalls Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PR
Recalled January 30, 2019 · FDA recall Z-0761-2019 · Stihler Electronic
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 · FDA Class II
Units
247 units
Sold at
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Description
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
Product
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.
Manufacturer(s)
Stihler Electronic Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →