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

Recall Z-2372-2015 — Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

U.S. FDA — Device Enforcement · United States · 2015-06-03 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2372-2015
Date of alert: 2015-06-03
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Elite Biomedical Solutions LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 49000204

Reported risk: Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

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-2372-2015 — Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

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