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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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