# FDA recall Z-0759-2019

> **Stihler Electronic Gmbh** · Class II · device recall initiated 2018-09-06.

## Product

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.

## 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

- **Recall number:** Z-0759-2019
- **Recalling firm:** Stihler Electronic Gmbh
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0759-2019

## Citation

> AI Analytics. FDA recall Z-0759-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0759-2019. Source: US FDA. Licensed CC0.

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