Hamilton Medical is recalling certain lots of coaxial breathing sets used to connect Hamilton ventilators to a patient tube or respiratory mask during ventilation, according to an FDA alert.
The FDA says Hamilton Medical Inc sent all affected customers an Urgent Medical Device Recall notice for certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit.
According to the FDA, this inner blue limb delivers fresh gas to the patient while the outer limb carries away exhaled gas and leakage from a cracked blue limb can lead to partial or complete rebreathing of exhaled gases.
Hamilton Medical ventilator coaxial breathing circuits are intended to connect Hamilton-C1/T1/MR1 ventilators to a patient tube or respiratory mask during ventilation, the FDA says.
The FDA warns that use of the affected product may cause serious adverse health consequences, including acute buildup of carbon dioxide (hypercapnia) that the body can’t remove (respiratory acidosis). If the problem goes unrecognized, it may cause organ dysfunction and death, the FDA says; however, there have been no reported injuries or deaths related to this issue.
List of Affected Products
| Product name | Part number | Lot numbers |
|---|---|---|
| Breathing circuit set, coaxial | 260128 | 199675 |
| Breathing circuit set, coaxial | 260128 | 199676 |
FDA Recommendations
- Do not use any breathing circuits from affected lots. Replace any affected breathing circuits in use with patients and discard the affected circuit.
- On June 27, 2025, Hamilton Medical, Inc. sent all affected customers an Urgent Medical Device Recall notice recommending the following actions:
- Review breathing circuit inventory.
- Stop use and quarantine any affected product.
- Replace any affected breathing circuit that is in use with a patient and discard the used affected circuit.
- Post the notice anywhere product may be stored.
- Contact the firm to arrange for product return.
- Return any units from the affected lot numbers to Hamilton Medical, Inc. with clearly marked outer packaging including the word “RECALL”.
- Distributors should forward the notice to any organization where potentially affected product has been transferred.
- Sign and return the acknowledgement form included with the letter.
