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:
Class I - Dangerous 🏥 Medical Devices
Recalled: July 30, 2025 Contract Medical International GmbH Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Contract Medical International GmbH
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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:
Product Codes/Lot Numbers:
Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2532-2025