Contract Medical International GmbH: Device Recall

Recall #Z-2532-2025 · 07/30/2025

Class II: Risk

Recall Details

Recall Number
Z-2532-2025
Classification
Class II
Product Type
Device
Recalling Firm
Contract Medical International GmbH
Status
Ongoing
Date Initiated
07/30/2025
Location
Dresden, N/A, Germany
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2500

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.

Product Description

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:

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.