Baxter Prismaflex System Recall for Connector Usage Safety Information
Baxter Healthcare is issuing a Class II recall for 133 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
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 text describes it as a communication of safety information regarding proper use rather than a defect causing injury or hospitalization, fitting the criteria for a voluntary precautionary recall or minor labeling/instruction issue.
Plain-English summary
Baxter Healthcare Corporation is recalling 133 units of the Prismaflex System, including the Prismaflex Control Unit. The recall is classified as Class II by the U.S. Food and Drug Administration. The affected products were distributed in the United States and Puerto Rico.
The recall is being conducted to communicate safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. The source text does not specify any reported injuries, illnesses, or specific defects beyond the need for this safety communication.
Healthcare providers and consumers should refer to the Prismaflex Operator's Manual for instructions on the proper use of connectors. No specific corrective actions, such as returns or refunds, are detailed in the provided source text.
The recalled product
- Product
- Prismaflex System, Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 133
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 (2)
- Product Code:955792
- GTIN 07332414126766
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 recalled by Baxter Healthcare Corporation 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.
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