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

Recall Z-2705-2014 — Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital,

U.S. FDA — Device Enforcement · United States · 2014-08-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2705-2014
Date of alert: 2014-08-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Vapotherm, Inc.
Product category: device
Product type: Devices

Reported risk: Disposable Patient Circuit that allows water to leak into the center gas lumen

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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