Z-0761-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 30, 2019
- Initiation Date
- September 6, 2018
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 247 units
Product Description
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 Pattern
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Code Information
Serial Numbers: UH07154 to UH07479