Baxter Prismaflex Control Unit Recalled for Potential Therapy Interruption
Baxter Healthcare 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 reports or high-risk medical device defects.
Plain-English summary
Baxter Healthcare Corporation is recalling 986 units of the Prismaflex Control Unit, specifically those running software versions below 7.21. The recall involves Product Code 113081 and all lot numbers. The devices were distributed nationwide to numerous U.S. states and territories, as well as internationally to countries in Asia, the Americas, and the EMEA region.
The recall is issued because 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. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and users of these devices should contact Baxter Healthcare Corporation for instructions on how to address the software issue and ensure patient safety.
The recalled product
- Product
- Prismaflex Control Unit, software versions below 7.21
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 986
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: 113081
- All Lot numbers
- GTIN: 07332414105266
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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