Recall Z-2167-2025 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Hamilton Medical AG
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.
| Date | Jul 30, 2025 (initiated Jun 26, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.