B. Braun Interventional Systems Celsite Implantable Access Port System, model ST301 recall — FDA Z-2382-2015
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Overview of recall records associated with B. Braun Interventional Systems, including dates, categories and classifications where available.
Classification mix: Class II: 1.
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
This page summarizes recall records in which the official source identifies B. Braun Interventional Systems 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.