FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Prismaflex Control Unit, software versions below 7.21
- Recall number
- Z-0278-2020
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Prismaflex Control Unit, software versions below 7.21
- Status
- Open, Classified
- Initiated
- 2019-10-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 988 units
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Hongkong, Indonesia, India, Japan, New Zealand, Taiwan, Korea, Singapore, Malaysia, Macau, Thailand, Vietnam, Canada, Argentina, Costa Rica, Cuba, Dominican Republic, Haiti, Barbados, Venezuela, St. Kitts, and EMEA.
- Lot, serial or model codes
- Product Code: 114870; All Lot numbers; GTIN: 07332414115395. Device not distributed in the US.
- 510(k) numbers
- ["K072093"]
- 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