FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Prismaflex Control Unit
- Recall number
- Z-2066-2020
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Prismaflex Control Unit
- Status
- Terminated
- Initiated
- 2020-04-07
- Posted
- not on file
- Terminated
- 2021-11-09
- Reason
- Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 5 devices US territories
- Distribution
- Distribution only to Puerto Rico and Guam
- Lot, serial or model codes
- Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.
- 510(k) numbers
- ["K131516"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28