Stihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk
Stihler Electronic Gmbh is recalling PRISMAFLO II S blood return warmers because damage to the heating profile may cause low-level skin burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (skin burns) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stihler Electronic Gmbh is recalling the PRISMAFLO II S blood return warmer (Product Code: PF2-WP31). This device is used for warming return blood flow in Prismaflex systems. The recall involves one unit with Serial Number E22368.
The recall is issued because damage to the Heating Profile (excluding the Control Unit) may result in a hotspot on the device. This hotspot may cause low-level skin burns to patients or users.
The product was distributed worldwide, including in the United States (California) and Switzerland. Users should stop using the affected device and contact the manufacturer for instructions on repair or replacement.
The recalled product
- 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.
- Manufacturer
- Stihler Electronic Gmbh
- Category
- Medical Device — Blood Warmer
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: E22368
Distribution
Part of a larger recall action
This product is one of 3 recalled by Stihler Electronic Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Stihler Electronic Gmbh
See all →- HighStihler PRISMAFLO II Blood Return Warmer Recalled for Burn Risk
FDA (Devices) · 2019-01-30
- HighStihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk
FDA (Devices) · 2019-01-30
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