FDA recall Z-0761-2019

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-09-06

Report date

2019-01-30

Termination date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stuttgart, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2019