Reported Jan 30, 2019 · Terminated

Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO…

Stihler Electronic GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stihler Electronic Gmbh · Julius-Holder-Str. 36 · Stuttgart, N/A · N/A

Is this the product you have?

  • Heating Profile PRISMAFLO II blood return
  • warmer for Prismaflex Product CodePF2-WP2618
  • Product UsageThe PRISMAFLO IIS warmer is used for warming return blood flow
Lot codes and dates
  • Serial NumbersUH07154 to UH07479
Amount recalled
247 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • CA

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 13, 2020 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.