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

Recall Z-2822-2020 — Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

U.S. FDA — Device Enforcement · United States · 2020-06-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2822-2020
Date of alert: 2020-06-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CareFusion 303, Inc.
Product category: device
Product type: Devices

Reported risk: LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

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.

Recall Z-2822-2020 — Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

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