Merit Medical Systems is recalling approximately 1,916 units of Prelude Sheath Introducers and Custom Procedure Kits because the devices were labeled as 7.5F size when they actually contain a smaller 7F size. This labeling error could lead medical professionals to select the wrong equipment during a surgical procedure. The recall involves specific lots of the PSI-7F-11-038 Version F and K12T-11077 models distributed across the United States and Mexico. No injuries have been reported, but the company is voluntarily removing the affected products from the market to ensure patient safety and procedural accuracy.
The use of a sheath introducer that is smaller than indicated on the label can cause compatibility issues with other medical tools designed for a 7.5F opening. This mismatch may lead to delays during surgery or clinical complications if the incorrect sizing is not discovered before or during the procedure.
Quarantine and contact manufacturer
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.
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Sources: FDA iRES · Raw API Response
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