Teleflex Medical is recalling a pediatric anesthesia breathing circuit because it can crack or break, which could interrupt treatment, cause breathing problems, or death.
What You Can Do & How an Anesthesia Injury Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting anesthesia breathing circuit induced injury cases in all 50 states. If you or somebody you know was injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
What is an Anesthesia Breathing Circuit?
It is a device that is used to deliver a mixture of anesthesia gases and/or other types of medical gases to a patient from a mechanical ventilator. The device mostly consists of a tube with an inhalation and exhalation route. It may also include a Y-piece, adaptor, or connector.
HCI Pediatric Anesthesia Breathing Circuit Recalled by Teleflex Medical
In September 2014, Teleflex Medical issued an “Urgent Medical Device Recall” letter to their customers, warning not to use the HCI Pediatric Anesthesia Breathing Circuit because it can crack or break.
On October 7, the U.S. Food and Drug Administration (FDA) issued a Class I recall and warned:
“The ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment and breathing difficulties if not replaced immediately. Use of this device may also cause death.”
The recall affects approximately 27,176 breathing circuits that were sold between June 2013 and May 2014. The devices are used in hospitals to care for pediatric patients. They were distributed throughout the United States and worldwide.
Recommendation
The FDA and Teleflex Medical are asking customers to stop using the devices immediately. The devices should be removed from inventory and should not be distributed. Customers should be notified if they may have received a device through re-distribution. Teleflex is asking customers to return a “Recall Acknowledgment Form.”
King Systems Universal Flex2 Breathing Circuit Recall
February 2009 — Approximately 500,000 of the King Systems Universal Flex2 Breathing Circuit have been recalled because the inner line may be severed or broken into two pieces. This could hinder the flow of oxygen and anesthetics to a patient, and possibly increase patient carbon dioxide levels.
Last year, King Systems Corp. received a warning letter from the FDA after inspectors found violations of good manufacturing standards at a facility that made anesthesia breathing circuits.
Soon afterward, the Universal Flex2 Breathing Circuit was recalled after a customer reported receiving a latex bag that was labeled as non-latex.
Do I have an Anesthesia Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting anesthesia breathing circuit induced injury cases in all 50 states. If you or somebody you know was injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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