Class I designations, the FDA’s most severe classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The R860 inspiratory safety guard is a breathing accessory intended for use with the Carescape R860 ventilator, which is designed to provide mechanical ventilation and breathing support to patients.
The devices are being recalled due to a risk of the safety guard disconnecting from the patient’s breathing circuit due to a manufacturing defect that may cause the outlet connector to have incorrect dimensions. Affected devices may result in the device not having a secure fit with the breathing circuit, which may result in the patient not receiving breathing support, the federal watchdog said.
No patient injuries have been reported in relation to the issue, but “there remains a risk of ventilation and oxygen-loss (hypoxia) should the patient’s airway become disconnected from the breathing circuit,” the FDA wrote in its recall notice.
GE Healthcare began notifying customers of the issue in October, outlining instructions for identifying the error and instructing them to return or destroy any incorrect and affected unused guards.
The recall affects a total of 307 GE Healthcare CareScape R860 inspiratory safety guards in the US with model numbers 2066713-001 for single packs and 2083208-001 for boxes of ten single packs, and with lot numbers 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130, 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129 and 18/00130. The recall only affects devices manufactured and distributed between August 2017 and September 2018, according to the release.
In November, GE Healthcare said that it closed out a full field inspection of all of its Millenium MG, MC and Myosight nuclear medicine systems after an incident in which the system malfunctioned.
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