Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
Reason for recall: Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used. Distribution: Domestic distribution nationwide. Foreign distribution to Colombia, Ecuador, Nicaragua, Panama, Thailand, Australia, Canada, and Lebanon. Quantity: 23,700 US; 5,225 OUS Lot/code info: UDI-DI: 30653405059930 Lot codes 202204294 202205134 202205164 202206084 202206154 202206204 202206304 202207074 202207084 202208014 202208044 202208084
30653405059930
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.