Recall Z-2532-2025— Contract Medical International GmbH

Name: FDA recall Z-2532-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-30

Class II · Ongoing

Class II FDA medical device recall by Contract Medical International GmbH, initiated 2025-07-30. It names one FDA 510(k) clearance: K153197. 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:. Reason: 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..

Recalling firm: Contract Medical International GmbH
Classification: Class II
Status: Ongoing
Initiated: 2025-07-30
Firm location: Dresden, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K153197 — Fortress Introducer Sheath SYstemContract Medical International, GmbH·cleared 2016-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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:

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.