Fortress Introducer Sheath (Contract Medical) – labeling error (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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:
Brand
Contract Medical International GmbH Lauensteiner Str. 37 Dresden Germany
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.
Contract Medical International GmbH Lauensteiner Str. 37 Dresden Germany is recalling Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/ due to 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 dev. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026