FDA DevicesClass I
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HA...
Published: July 8, 2026Recall ID: Z-2463-2026Category: devicesCountry: US
Reason for Recall / Hazard
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Product Description & Identification
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Additional Source Details
| Field | Value |
|---|---|
| City | Domat/Ems |
| State | N/A |
| Event id | 99028 |
| Address 1 | Parc Industrial Vial 10 |
| Address 2 | N/A |
| Code info | REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.) |
| Postal code | N/A |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 27,270 pcs |
| Reason for recall | Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260529 |
| Initial firm notification | Letter |
| Center classification date | 20260630 |
Overview
- Recalling FirmHamilton Medical AG
- StatusOngoing
- Risk LevelClass I
- DistributionUS Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR, OH, PA, CA, CO, ID, AZ, ME, MO, MI, IL, OR, VA, FL, NJ, SD, NY, NM, TN, CT, NE, OK, AL, GA, KY, NH, WY, ND, IN, UT, WV, DE, IA, PR, MN, LA, AK, HI.