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.
Recall
- Recall Number
- Z-2167-2025
- Event Number
- 97222
- Firm
- Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland
- FEI Number
- 3014766741
- Product Code
- BZO
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 26, 2025
- Posted
- July 30, 2025
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.
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.
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 [email protected] If you have any questions contact firm at: [email protected] and 800-426-6331
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.
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