Prismaflex Control Unit
This recall has been terminated (originally issued April 7, 2020).
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- April 7, 2020
- Terminated
- November 9, 2021
- Recall Number
- Z-2066-2020
- Quantity
- 5 devices US territories
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Distribution
Distribution only to Puerto Rico and Guam
Lot / Code Info
Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
Root Cause
Under Investigation by firm
Action Taken
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.