Baxter Healthcare Corporation Prismaflex Control Unit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Prismaflex Control Unit
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Product Code: 114870, Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
Products Sold
Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
Baxter Healthcare Corporation is recalling Prismaflex Control Unit due to Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Recommended Action
Per FDA guidance
Baxter notified customers on about 04/07/2020 via "URGENT MEDICAL DEVICE RECALL" letter. The letter instructed customers that the affected units can still be used until the replacement is performed, a local Baxter representative will contact each facility to schedule the replacement of affected devices, complete and return the Baxter Customer Reply Form by scanning and e-mailing it to perezd2@baxter.com, and if the affected devices have been further distributed, to please notify those customers by forwarding a copy of the recall notification. For general questions, contact Baxter Customer Service at 787 866 70 27, between the hours of 7:00 am to 4:00 pm local 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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026