Class 2 Device Recall Fortress Introducer Sheath System

• Date Initiated by Firm: July 30, 2025
• Date Posted: September 05, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2532-2025
• Recall Event ID: 97423
• 510(K)Number: K153197
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
• Code Information: Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.
• Recalling Firm/ Manufacturer: Contract Medical International GmbH; Lauensteiner Str. 37; Dresden Germany
• For Additional Information Contact: Timothy Desaulniers; 1-612-3252003
• Manufacturer Reason for Recall: Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
• FDA Determined Cause: Under Investigation by firm
• Action: On July 30, 2025, the firm notified affected consignees via email. Customers were instructed to verify if the labeling information on received products is consistent. If customers identify incorrect labeling, they should contact Contract Medical International GmbH for replacement.
• Quantity in Commerce: 2500
• Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, GA, KY, MA, MI, MO, NJ, NY, OR, RI, SC, TN, TX and the countries of Switzerland, Hungary, Italy, France, Denmark, Austria, Australia, Belgium, Poland, Germany, Bulgaria, Kazakhstan, Finland, Ireland, South Korea, Taiwan, Israel, Spain, Vietnam, Malaysia, Czechia, Thailand, Libya, Great Britain, Chile, Slovakia, Slovenia, Croatia, Sweden, Argentina.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DYB