Busse Hospital Disposables, Inc. is recalling 1,481 medical kits, including Tracheostomy Care Trays, Dressing Change Trays, and Tracheostomy Care Sets, because they contain Nurse Assist Sterile 0.9% Normal Saline that may not be sterile. The manufacturer of the saline identified that the required sterility assurance level cannot be guaranteed, meaning the product could be contaminated with bacteria. These kits are used in clinical and home healthcare settings for wound care and airway maintenance. Consumers should contact their healthcare provider or the manufacturer for instructions on how to handle affected kits.
Using non-sterile saline can lead to serious health complications such as bloodstream infections, urinary tract infections, or respiratory infections. In the most severe cases, patients may develop sepsis, which can be life-threatening or lead to death.
Risk of infection due to non-sterile saline component
“RER No. and Lot location description”
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · FDA Press Release · Raw API Response
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