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Flow-c and Flow-e Anesthesia Systems Recalled

Wednesday September 7th, 2022 Defective Medical Devices, Firm News

If you or a loved one experienced breathing or blockage issues during a surgical procedure due to a faulty suction unit, you may have a case against the manufacturer.

In May 2022, Getinge USA Sales Inc. recalled Flow-c and Flow-e Anesthesia Systems due to reports of cracked or broken suction system power switches. The U.S. Food and Drug Administration (FDA) classified the recall as Class 1 due to the risk of serious injury or death. In total, 64 devices in the U.S. were affected and the devices were distributed between June 2, 2020, and February 15, 2022.

Getinge Flow-c and Flow-e Anesthesia Systems are used to provide inhalation anesthesia and control ventilation for patients who have no or limited ability to breathe. They are used by patients ranging in age from newborns to adults. The systems are operated by anesthesiologists in hospital settings.

Getinge received reports of cracked or broken on/off power switches on the system’s suction unit. If the switch breaks, the suction unit will not work which means that fluids such as phlegm, blood, or stomach (gastric) content will not be removed from the patient’s mouth or airways. The problem can cause delays during a procedure or in between procedures. If the suction device does not work for a prolonged period of time, fluids could block a patient’s ability to breathe.

The risks of such blockages include:

  • Choking
  • Inability of oxygen to make it into the blood (acute respiratory failure or ARDS)
  • Lung infection (pneumonia) that prevents oxygen from getting into the blood (respiratory failure)
  • Brain injury caused by lack of oxygen in the brain (hypoxia)
  • Death

So far Getinge has received 21 complaints about the Flow-c and Flow-e Anesthesia Systems.

How Goldenberg Lauricella Can Help You

If you or a loved one were injured by a Flow-c or Flow-e Anesthesia System, contact the Medical Device Lawyers at Goldenberg Lauricella. Our team has more than 35 years of experience getting our clients the justice they deserve. Medical device lawsuits are complicated, and you need a legal team that has a proven track record of success and expertise. Here at Goldenberg Lauricella, we have the expertise, experience, and compassion to provide you the Gold standard of advocacy. Contact us today for a free consultation.

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