FDAJune 26, 2025device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
hamilton medical aghamiltonhamilton medical
UPCs
07630002802963
Recall history
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