Prismaflex 7.XX

• FDA 510(k) K131516 decided 3 Jan 2014 Active
• FDA GUDID UDI-DI 07332414117702 listed 9 Oct 2015 Listed

• • Terminated Z-1279-2021 FDA Class II ·initiated 28 Jan 2021

  Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

• • Terminated Z-2066-2020 FDA Class II ·initiated 7 Apr 2020

  Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

• 2 recalls, same reason

  • Terminated Z-1925-2018 FDA Class II ·initiated 24 Apr 2018
  • Terminated Z-1926-2018 FDA Class II ·initiated 24 Apr 2018

  Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.

1. 3 Jan 2014 Cleared FDA 510(k) K131516
2. 9 Oct 2015 Listed FDA GUDID 07332414117702
3. 24 Apr 2018 Recall initiated FDA recalls Z-1925-2018
4. 24 Apr 2018 Recall initiated FDA recalls Z-1926-2018
5. 7 Apr 2020 Recall initiated FDA recalls Z-2066-2020
6. 28 Jan 2021 Recall initiated FDA recalls Z-1279-2021

Trade name

Prismaflex

Generic name

Haemodialysis system, institutional

Model / Ref / Catalog

7.XX, 115269

Primary DI / UDI-DI

07332414117702

510(k) Number

K131516 ↗

FDA product code

KDI

GMDN term

Haemodialysis system, institutional

Device class

Class II

Regulation number

876.5860

GUDID distribution status

In Commercial Distribution

Category: Haemodialysis system, institutional

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• FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 by Fresenius Medical Care North America
• COBE HC 700 MIDI HEMOCONCENTRATOR by Hospal Industrie

• Mars Treatment Kit Type 1116/1 - X-Mars Us 800541

  Class II

  FDA 510(k) K133807 Active Cleared 26 Mar 2014 GUDID on market

• Prismaflex 7.20

  Class II

  FDA 510(k) K131516 Active Cleared 3 Jan 2014 GUDID on market

• MARS Monitor 800437

  Class II

  GUDID on market

• Gambro-Engstrom Erica IV Respirator

  Class II

  FDA 510(k) K872482 Active Cleared 3 Mar 1988

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