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

Recall Z-2167-2025 — Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

U.S. FDA — Device Enforcement · Switzerland · 2025-06-26 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2167-2025
Date of alert
2025-06-26
Country / jurisdiction
Switzerland
Risk level
Class I
Risk type
recall
Brand
Hamilton Medical AG
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07630002802963
Reported risk: Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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