Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Check against the official notice below — it lists the full affected range.
Getinge Usa Sales Inc is recalling the Flow-c Anesthesia System (Product Code 6887700), which is used to administer anesthesia while controlling patient ventilation. The recall affects 17 units distributed in Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia. The problem involves a potential crack that may form on the on/off switch of the suction unit, which could result in unreasonable risk of harm to patients and, in worst-case scenarios, prevent the suction unit from being activated entirely.
The affected devices have specific serial numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, and 5078 (UDI-DI: 07325710009765). The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
Reason for recall: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated. Distribution: US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia Quantity: 17 units US Lot/code info: UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.