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.
What this means for you
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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Stihler Electronic Gmbh is recalling 821 units of the PRISMAFLO II S blood return warmer, product code PF2-WP33. The affected units have serial numbers ranging from E22000 to E23999. These devices are used for warming return blood flow in Prismaflex systems.
The recall is due to a potential defect where damage to the Heating Profile (excluding the Control Unit) may result in a hotspot. This condition may cause low-level skin burns to patients or users.
The affected products were distributed worldwide, including nationwide in the United States (specifically California) and in Switzerland. Consumers and healthcare facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- Stihler Electronic Gmbh
- Category
- Medical Device — Blood Warmer
- Hazard
- Affected units
- 821
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: E22000 to E23999
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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