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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
Plain-English summary
Baxter Healthcare Corporation is recalling 1,014 Prismaflex Control Units equipped with software versions below 7.21. The recall covers units distributed nationwide across the United States and internationally to numerous countries in Asia, the Americas, and Europe.
The recall is issued because communication error alarms may result in the interruption or delay of therapy. Additionally, these errors may lead to blood loss due to the non-restitution of blood in the extracorporeal circuit.
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
- 1,014
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: 115269 (GTIN: 07332414117702)
- 955542 GTIN: 07332414124236)
- All Lot numbers
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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