Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1926-2018 — Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients wei

U.S. FDA — Device Enforcement · United States · 2018-04-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1926-2018
Date of alert: 2018-04-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Baxter Healthcare Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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