U.K. regulators issued a safety alert for some endotracheal tubes produced by Unomedical, a subsidiary of ConvaTec. The U.K. Medicines & Healthcare Products Regulatory agency is asking healthcare providers to identify and return affected devices to ConvaTec.
The damaged devices are sold under 3 product names: the Unomedical UnoFlex, the Euromedical TrachealFlex and the PharmaPlast The endotracheal tubes are single-use products used to provide an unobstructed airway to and from the lungs.
The lamination in affected tubes may detach from the plastic inner layer, constricting airflow to the patient. The detaching lamination was due to poor adhesion, and the manufacturing problem has been addressed, according to the alert.
The field notice was initially issued in March, but Unomedical followed up with another warning after it had not heard back from ‘a significant number of users" to confirm that the devices would be returned or otherwise kept from use.
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