Reported Sep 17, 2025 · Ongoing
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number:…
Contract Medical International GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Contract Medical International GmbH · Lauensteiner Str. 37 · Dresden, N/A · N/A
Is this the product you have?
- Brand NameFortress
- Introducer Sheath System Product NameFortress Introducer
- Sheath System Model/Catalog Number386594
- Product DescriptionFortress Introducer Sheath System, 6F
- Straight 45cm—
- Lot codes and dates
- Lot CodeModel
- Number386594
- Lot Number800989
- Unique Device Identifier04251244503703
- Expiration Date31 OCT 2027
- Amount recalled
- 2500
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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