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

Recall Z-1280-2021 — Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

U.S. FDA — Device Enforcement · United States · 2021-01-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1280-2021
Date of alert: 2021-01-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Baxter Healthcare Corporation
Product category: device
Product type: Devices

Reported risk: 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.

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

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Recall Z-1280-2021 — Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

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