Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 3865
FDA device recall Z-2532-2025 · posted 2025-09-05 · Open, Classified
Recall details
- Recalling firm
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 2500
- Distribution
- 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
- Date initiated
- 2025-07-30
- Date posted
- 2025-09-05
- Location
- Dresden, Germany
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Fortress Introducer Sheath SYstem (K153197) | Contract Medical International, GmbH | 2016-01-11 |