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

Recall Z-1121-2015 — Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour a

U.S. FDA — Device Enforcement · United States · 2014-11-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1121-2015
Date of alert: 2014-11-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Pulsion Medical Inc
Product category: device
Product type: Devices

Reported risk: Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

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.

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