Baxter Prismaflex System Recall for Connector Usage Safety Information
Baxter Healthcare is recalling 555 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 and involves communicating safety information regarding proper use, which aligns with the rubric for voluntary precautionary recalls or minor issues without reported injuries.
Plain-English summary
Baxter Healthcare Corporation is recalling 555 units of the Prismaflex System, including the Prismaflex Control Unit. The recall is being conducted to communicate safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the system.
The affected units were distributed in the United States and Puerto Rico. The product is identified by Product Code 115269 and GTIN 07332414117702.
Consumers and healthcare facilities should refer to the Prismaflex Operator's Manual for instructions on the proper use of connectors to ensure safe operation of the device.
The recalled product
- Product
- Prismaflex System, Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 555
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:115269
- GTIN 07332414117702
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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