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

Recall Z-0445-2016 — Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

U.S. FDA — Device Enforcement · United States · 2015-11-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0445-2016
Date of alert: 2015-11-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CareFusion 303, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15086733

Reported risk: CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.

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-0445-2016 — Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

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