Z-0761-2019 Class II Terminated

Recalled by Stihler Electronic Gmbh — Stuttgart, N/A

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