Hospira Inc. is recalling approximately 2,962,342 medical irrigation and extension sets because the Tyvek packaging cover may not be completely sealed. This defect can create openings at the edge of the sterile package, potentially exposing the sterile contents to the environment before use. The recall includes five different types of products, including Latex-Free Extension Sets, Nonvented Y-Sets for Transurethral Resection, Cystoscopy/Irrigation Sets, Large Bore Y-Irrigation Sets, and 4-Lead T-U-R Irrigation Sets. These products were distributed nationwide in the U.S. and several foreign countries between 2012 and 2014.
A compromised package seal allows air and contaminants to enter the sterile packaging, which can lead to infection or serious illness in patients if a non-sterile device is used during medical procedures like bladder irrigation or surgery.
Quarantine and return product instructions
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 · Raw API Response