ICU Medical, Inc. is recalling approximately 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the device body, or tear. These needle-free connectors are used in hemodialysis and intravascular therapy; a damaged seal can cause fluid leaks, block the flow of medicine, or accidentally allow air to enter a patient’s bloodstream. If the seal fails, it could also lead to contamination or delays in critical therapy.
A damaged or separated silicone seal can lead to air being infused into the body (air embolism), which is potentially life-threatening. It also poses a risk of biological contamination and therapy interruption if blood products cannot be properly injected or withdrawn.
Units manufactured in the United States and distributed worldwide for use in hemodialysis and vascular access.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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