Recall Z-2167-2025— Hamilton Medical AG
Class I · Ongoing
Class I FDA medical device recall by Hamilton Medical AG, initiated 2025-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Hamilton Medical AG
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-06-26
- Firm location
- Domat/Ems, Switzerland
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.