Stuttgart, N/A, Germany
Stihler Electronic Gmbh recalls
1 recall recorded since 2018, most recently on 6 September 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 6 September 2018
- Terminated
- 13 May 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0760-2019, Z-0759-2019, Z-0761-2019
- 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.
- Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.