FDA announces recall on ventilator components after 4 serious injuries
After being linked to four serious injuries, the U.S. Food and Drug Administration (FDA) is spreading awareness of a recall on a line of coaxial breathing circuits, used in Hamilton Medical ventilators.
According to the FDA, Hamilton said the issue is linked to an expiratory valve set that is not performing as intended, potentially impairing gas flow. The valve can attach itself to the sealing ring, with the malfunction occurring nearly immediately after the ventilators begin breathing for a patient.
The problem should trigger the “Exhalation Obstructed” alarm on the ventilation units, signaling that expiratory gas flow is impeded. The issue has been associated with Hamilton C-1, Hamilton T-1 and Hamilton MR-1 ventilators, all of which use the same coaxial breathing circuit sets, which connect to a respiratory mask during ventilation.
The company announced the recall on the defective parts in July, noting at the time that there have been no deaths associated with the manufacturing error.
However, due to the risks associated with improper ventilator function—including hypoxemia, possibly leading to organ failure and death—the FDA has designated this recall a Class I, the most serious type.
What is being recalled?
Recalled breathing circuit sets can be identified using the following chart. All potentially defective devices must be removed from where they are used or sold.
Product Name | Brand Name | Product Number | UDI-DI |
T1 CIRCUIT 240 +VALVE B/10 | Hamilton Breathing circuit sets, coaxial | 260127 | |
T1 CIRCUIT 180 +VALVE B/20 | Hamilton Breathing circuit sets, coaxial | 260128 | |
MR1 CIRCUIT 300 +VALVE B/10 | Hamilton Breathing circuit sets, coaxial | 260167 | |
MR1 CIRCUIT 480 +VALVE B/8 | Hamilton Breathing circuit sets, coaxial | 260168 |
Next steps
The FDA was clear in stating that the affected coaxial breathing circuit sets must not be used for patient care. All stocks should be checked for the matching product numbers and UDIs.
Customers should have received a letter from Hamilton containing instructions on how to initiate a return. Those with questions are advised to contact the company at [email protected] or call 1-800-426-6331.
Any provider aware of an adverse event associated with this recall is asked to report it to the FDA’s MedWatch program.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.