Baxter Recalls Prismaflex Control Units Lacking FDA Clearance
Baxter Healthcare is recalling five Prismaflex Control Units distributed to Puerto Rico and Guam because they lack FDA regulatory clearance.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states no illnesses or injuries were reported and the hazard is regulatory (lack of clearance) rather than a physical defect causing harm, fitting the 'voluntary precautionary' or 'minor' criteria for a score of 2.
Plain-English summary
Baxter Healthcare Corporation is recalling five Prismaflex Control Units (Product Code 114870) that were inadvertently distributed without FDA regulatory clearance. The affected devices are identified by Lot Numbers PA18198, PA18199, PA18238, PA22556, and PA22558.
The recall is limited to distribution in Puerto Rico and Guam. The source text does not report any illnesses, injuries, or deaths associated with these devices.
Healthcare facilities and consumers who possess these specific units should stop using them and contact Baxter Healthcare Corporation for instructions on return or replacement.
The recalled product
- Product
- Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 5
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 (6)
- Product Code: 114870
- Lot Number: PA18198
- PA18199
- PA18238
- PA22556
- PA22558.
Distribution
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