Baxter Recalls Prismaflex Control Units Due to Software and Usage Issues
Baxter Healthcare is recalling 3,440 Prismaflex Control Units worldwide due to reports of operators failing to follow safe unloading instructions and software errors in specific versions.
What this means for you
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, and the hazard involves a risk of harm from improper device operation and software errors, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Baxter Healthcare Corporation is recalling 3,440 units of the Prismaflex Control Unit, a medical device used for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE). The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall was initiated after the firm received reports of device operators failing to adhere to instructions for use regarding the safe unloading of disposable sets from the unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may unintentionally revert to safe default values.
Affected product codes include 6023014700, 107493, 113081, and 115269. The recall applies to all serial numbers and software versions 4.1x, 5.10, 6.10, 7.xx, and 8.00. Healthcare providers should contact Baxter Healthcare for further instructions on managing the affected devices.
The recalled product
- Product
- Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 3,440
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 (10)
- Product code: 6023014700
- 107493
- 113081
- 115269
- Serial Number: All
- Affected Software Versions: SW 4.1x
- 5.10
- 6.10
- 7.xx
- 8.00
Distribution
Distributed nationwide across the United States.
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