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

Recall Z-2592-2021 — Atrium Pneumostat Chest Drain Valve, Part Number 16100

U.S. FDA — Device Enforcement · United States · 2021-08-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2592-2021
Date of alert
2021-08-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Atrium Medical Corporation
Product category
device
Product type
Devices
Reported risk: The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
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.

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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.