Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H

FDA device recall Z-2167-2025 · posted 2025-07-30 · Open, Classified

Recall details

Recalling firm

Hamilton Medical AG

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.

Action taken

Starting on 6/26/2025, recall notices were emailed to customers who were asked to do the following: Return affected devices. If one of the affected breathing circuits would be already in use with a patient, it is requested to exchange it and discard the product after replacement. If you are a distributor, please forward to any organization where potentially affected product has been transferred. Complete and return the acknowledgement form via email to complaints@hamiltonmedical.com If you have any questions contact firm at: complaints@hamiltonmedical.com and 800-426-6331

Root cause

Process control

Status

Open, Classified

Product code

BZO

Quantity affected

2,560

Distribution

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.

Date initiated

2025-06-26

Date posted

2025-07-30

Location

Domat/Ems, Switzerland