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

Recall Z-2001-2020 — Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23

U.S. FDA — Device Enforcement · United States · 2020-01-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2001-2020
Date of alert
2020-01-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Reported risk: Inability for the guidewire to pass through the needles included with the catheter kits.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.