The United States Food and Drug Administration has announced the recall of Getinge USA Sales Incorporated’s Flow-c and Flow-e Anesthesia Systems due to defective suction system power switches. The FDA has categorized the recall as a Class I recall, which is the most serious type of recall. Class I recalls involve products that can cause serious injuries or death.
The product is known as the Flow-c and Flow-e Anesthesia Systems and has a product code of 6887700 or 6887900. The devices were distributed from June 2, 2020, until February 15, 2022.
The Getinge Flow-c and Flow-e Anesthesia Systems provide inhalation anesthesia and ventilation control for patients who cannot breathe on their own. These anesthesia systems can help support the breathing of patients who have limited ability to breathe on their own. The recalled anesthesia system is used with patients who range in age from newborns to adults and can only be operated by a trained anesthesiologist in a hospital setting.
Getinge initiated the recall of their Flow-c and Flow-e Anesthesia Systems following reports of broken and cracked on/off switches on the suction unit. Should the on/off switch break, the suction unit won’t operate to remove blood, phlegm, blood, or stomach fluids from the patient’s mouth and airway.
This problem can cause a delay during a procedure causing the patient’s airway to be blocked, preventing the patient from breathing. When a patient’s airway is blocked, the patient could suffer the following:
- Lung infections
- Acute respiratory failure or ARDS
- Brain injury (hypoxia)
The recall report states that there have been at least 21 complaints about the device. No injuries or deaths have been reported at this point.
Health care providers and anesthesiologists who use the Flow-c or Flow-e Anesthesia System are affected by this recall. Getinge USA Sales mailed a Medical Device Correction letter to affected risk managers. Their letter recommends that all affected customers inspect inventory to determine if they have any recalled Flow-c and/or Flow-e anesthesia system(s. The device’s serial number can be found on the device’s product label.
If the on/off switch is broken or cracked, the anesthesia machine should be replaced with a functioning unit or use an alternative suction device.
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