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Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation

The FDA is aware that Hamilton Medical, Inc. has sent all affected customers an Urgent Medical Device Recall notice for certain lots of coaxial breathing sets. This recall is 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. This inner blue limb delivers fresh gas to the patient while the outer limb carries away exhaled gas. Leakage from a cracked blue limb can lead to partial or complete rebreathing of exhaled gases.

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.

There have been no reported injuries or deaths related to this issue.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with questions about this recall should contact Hamilton Medical, Inc. at 800-426-6331 or complaints@hamiltonmedical.com.