Merit Medical Systems, Inc. is recalling 40 units of its Prelude IDEAL 4 F Hydrophilic Sheath Introducers. These medical devices, used during surgical procedures, may have been packaged with 5F dilators despite being labeled as containing 4F dilators. The recall specifically affects Lot H3082668 with an expiration date of November 14, 2024. No injuries or incidents have been reported to date.
The use of an incorrectly sized dilator may lead to procedure delays while surgical staff locate and prepare the correct equipment. While no injuries have been reported, such delays in a clinical setting can disrupt surgical workflows.
Quantity affected: 40 units; Recall number: Z-1434-2025
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.