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

Recall Z-0276-2020 — Prismaflex Control Unit, software versions below 7.21

U.S. FDA — Device Enforcement · United States · 2019-10-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0276-2020
Date of alert
2019-10-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07332414073718
Reported risk: 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.
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.

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