Baxter Prismaflex Control Unit Recalled for Communication Error Alarms
Baxter Healthcare is recalling 336 Prismaflex Control Units with software versions below 7.21 due to communication error alarms that may interrupt therapy or cause blood loss.
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 involves a medical device defect that poses a risk of harm (blood loss, therapy interruption) but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 336 units of the Prismaflex Control Unit, specifically those running software versions below 7.21. The recall is due to a defect where communication error alarms may result in the interruption of therapy, a delay in therapy, or blood loss due to the non-restitution of blood in the extracorporeal circuit.
The affected devices were distributed nationwide to 48 states and the District of Columbia, as well as internationally to numerous countries including Australia, Canada, China, India, Japan, and various locations in Europe, Asia, and the Americas. The recall covers all lot numbers for Product Code 6023014700.
Healthcare facilities and users should contact Baxter Healthcare Corporation for instructions on how to address the software defect and ensure patient safety. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Prismaflex Control Unit, software versions below 7.21
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 336
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 (3)
- Product Code: 6023014700
- All Lot numbers
- GTIN: 07332414073718.
Distribution
Part of a larger recall action
This product is one of 5 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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