Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Recalled by Contract Medical International GmbH Due to Units may have been packaged with an incorrect...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Contract Medical International GmbH directly.
Affected Products
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:
Quantity: 2500
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Contract Medical International GmbH
Contract Medical International GmbH has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report