Baxter Healthcare Corporation Prismaflex Control Unit, software versions below 7.21 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Prismaflex Control Unit, software versions below 7.21
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Product Code: 107493, All Lot numbers, GTIN: 07332414073718
Products Sold
Product Code: 107493; All Lot numbers; GTIN: 07332414073718
Baxter Healthcare Corporation is recalling Prismaflex Control Unit, software versions below 7.21 due to Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporea. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Recommended Action
Per FDA guidance
Baxter Healthcare notified customers on about 10/04/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that Prismaflex Control Units with software versions 7.20 and below have the potential to produce communication errors. Instructions included that operators may continue to use the control units until the upgrade is performed, but if a communication error alarm does occur, follow the instructions presented on the graphical user interface and/or in the operators manual. It must be reinforced that it is important to manually return the extracorporeal blood to the patient, and re-train users on this process, outlined on page 10:57 of the operators manual, if necessary. A local Baxter service representative will contact your facility to determine the correction plan and schedule the software upgrade. If the affected devices was purchased from Baxter, complete the provided Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. For a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures. Questions regarding this recall can be directed to Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026