FDA designates recall of Hamilton breathing circuits a Class I
The U.S. Food and Drug Administration (FDA) is alerting the public to an urgent recall of coaxial breathing circuits manufactured by Hamilton Medical. The company sent all known customers a letter on June 27, advising them of a defect that impacted multiple lots of the devices. The letter contained instructions on how to initiate a return, as the breathing circuits cannot be safely used.
A defective blade used to cut the tubing may cause it to crack instead, potentially compromising the flow of oxygen and other breathing gases. Specifically, the damage could mix up the flow of gases inhaled and exhaled, possibly leading to a buildup of carbon dioxide in the blood.
There have been no reported injuries. However, due to the risk of serious health consequences linked to such a defect, the FDA has labeled this recall a Class I, the most serious designation.
What is being recalled?
Two lots of Hamilton coaxial breathing circuits are subject to this recall (see chart below). The tubes are connected to ventilator systems; however, no other parts or devices have been deemed defective.
Next steps
The FDA and Hamilton ask all providers and suppliers to check their inventories for the affected breathing circuits. If any are found, they must be quarantined to ensure they are not used on patients.
Customers who received a letter from Hamilton can initiate a return using the provided form. Everyone else is asked to contact the company at 800-426-6331 or [email protected].
The full recall notice can be found here.
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