Fortress Introducer Sheath System recall — FDA Z-2532-2025
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…
Overview of recall records associated with Contract Medical International GmbH, including dates, categories and classifications where available.
Classification mix: Class II: 1.
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…
This page summarizes recall records in which the official source identifies Contract Medical International GmbH as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.