Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk
Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of blood loss and therapy interruption, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
Baxter Healthcare Corporation is recalling 988 units of the Prismaflex Control Unit with software versions below 7.21. The recall is due to a defect where communication error alarms may result in the interruption or delay of 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 those in Asia, the Americas, and Europe. The product code is 114870, and the recall applies to all lot numbers.
Healthcare facilities and users should contact Baxter Healthcare Corporation for instructions on how to address the software defect and ensure patient safety.
The recalled product
- Product
- Prismaflex Control Unit, software versions below 7.21
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 988
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: 114870
- All Lot numbers
- GTIN: 07332414115395. Device not distributed in the US.
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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