FDA Device recall Z-0760-2019
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used fo…
- FDA Device
- Class II
- terminated
- Published 2019-01-30
On 2019-01-30 the FDA classified a Class II recall of Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP31 Product Usage: The PRISMAFLO IIS warmer is used fo… by Stihler Electronic, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0760-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-06 |
| Published | 2019-01-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stihler Electronic |
| Distribution | US |
Product
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.
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
Identifiers
| code_info | Serial Numbers: E22368 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0760-2019%22
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