Baxter Prismaflex System Safety Communication on Connector Use
Baxter issued a safety communication regarding the proper use of connectors with the Prismaflex System and Control Unit.
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 source describes a safety communication regarding proper use rather than a defect causing injury, fitting the criteria for a voluntary precautionary recall or minor labeling/instruction issue.
Plain-English summary
Baxter Healthcare Corporation is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. This action involves the Prismaflex System and Prismaflex Control Unit.
The recall number for this action is Z-1830-2020. The agency classification is Class II. The distribution pattern includes the US and Puerto Rico.
Users should refer to the Prismaflex Operator's Manual for proper connector usage instructions.
The recalled product
- Product
- Prismaflex System, Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 2,471
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: 114870
- GTIN 07332414115395
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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