Z-2532-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- July 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2500
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:
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.
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.
Code Information
Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.