Baxter Prismaflex System Recall for Connector Safety Information
Baxter is recalling 1,225 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
What this means for you
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 a Class II recall involving the communication of safety information regarding proper use, which fits the criteria for moderate severity as it involves a potential risk of harm but is primarily informational.
Plain-English summary
Baxter Healthcare Corporation is recalling 1,225 units of the Prismaflex System, 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 products were distributed in the US and Puerto Rico. The product code is 113081 and the GTIN is 07332414105266.
Consumers and healthcare providers should refer to the Prismaflex Operator's Manual for the proper use of connectors with the Prismaflex system.
The recalled product
- Product
- Prismaflex System, Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,225
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: 113081
- GTIN 07332414105266
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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