Recall Z-2532-2025 ยท DYB Introducer, Catheter
Contract Medical International GmbH
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:
| Date | Sep 5, 2025 (initiated Jul 30, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 | 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, Sp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153197 | Fortress Introducer Sheath SYstem Contract Medical International, GmbH, Jan 11, 2016 |