Prismaflex 7.20

• FDA 510(k) K131516 decided 3 Jan 2014 Active
• FDA GUDID UDI-DI 07332414124236 listed 24 Nov 2017 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. 24 Nov 2017 Listed FDA GUDID 07332414124236
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

7.20, 955542

Primary DI / UDI-DI

07332414124236

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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• ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM by Althin Medical AB an Affiliate of Baxter Intl
• CLIRANS E-SERIES HOLLOW FIBER DIALYZERS by TERUMO MEDICAL CORPORATION
• AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory by Baxter Healthcare Corportation

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

• MARS Monitor 800437

  Class II

  GUDID on market

• Prismaflex 7.XX

  Class II

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

• Gambro-Engstrom Erica IV Respirator

  Class II

  FDA 510(k) K872482 Active Cleared 3 Mar 1988

See all devices from Gambro, Inc. →