Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2167-2025

June 26, 2025

Class I

Product summary

Firm
Hamilton Medical AG
Event
Event 97222
Status
Ongoing
Classification
Class I
Quantity
2,560
Official record key
device-enforcement:Z-2167-2025

Official wording

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.

Code information: UDI-DI: 07630002802963, Lots: 199675, 199676

Distribution pattern: US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC, NJ, UT, TX, GA, SC, VA, IN, SD, MO, OR, TN, MA, AZ, NM.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.