Baxter Recalls Prismaflex Control Units Due to Tubing Performance Variability
Baxter Healthcare is recalling Prismaflex Control Units because tubing variability may cause alarms during self-tests. The units are used for Continuous Renal Replacement Therapy.
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 classified as FDA Class II. The hazard is described as leading to alarm situations, which is a functional defect without explicit reports of injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corporation is recalling 4,946 units of the Prismaflex Control Unit. These devices are used for Continuous Renal Replacement Therapy (CRRT). The recall is due to variability in the performance of the tubing in the Automatic Repositioning System (ARPS) Pump Assembly.
This performance variability may lead to alarm situations during or after a system self-test. The affected units were distributed worldwide, including in the United States, Puerto Rico, Guam, and numerous international locations.
Healthcare facilities and users should stop using the affected Prismaflex Control Units and contact Baxter Healthcare Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 4,946
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 (20)
- GTIN 07332414073718 (Product code 107493)
- serial numbers PA0105
- PA0104
- PA0106
- PA0102
- PA0107
- PA0112
- PA0111
- PA0117
- PA0113
- PA0120
- PA0127
- PA0124
- PA0130
- PA0132
- PA0131
- PA0134
- PA0128
- PA0136
- PA0141
Distribution
Part of a larger recall action
This product is one of 4 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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