Baxter Prismaflex System Recall for Connector Usage Safety Information
Baxter Healthcare is recalling 626 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'High' severity score under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 626 units of the Prismaflex System, specifically 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 products were distributed in the United States and Puerto Rico. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and consumers should stop using the affected Prismaflex Systems and refer to the Prismaflex Operator's Manual for the proper use of connectors. Baxter Healthcare is the recalling firm responsible for this action.
The recalled product
- Product
- Prismaflex System, Prismaflex Control Unit
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 626
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:955542
- GTIN 07332414124236
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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