Contract Medical International GmbH is recalling 2,500 units of the Fortress Introducer Sheath System (6F Straight 45cm) because they were packaged with incorrect labels. The labels incorrectly identify the devices as the smaller 4F version, listing the wrong reference number and Unique Device Identifier (UDI). This recall specifically affects products with Lot Number 800989 and an expiration date of October 31, 2027.
If a physician relies on the incorrect labeling, they may attempt to use the device with incompatible 4F surgical accessories. This could lead to procedural errors, delays in treatment, or surgical complications.
Units were packaged with an incorrect pouch label listing the reference number and UDI of the 4F version instead of the 6F version.
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.