Natus Medical EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only recall — FDA Z-0635-2024
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Overview of recall records associated with Natus Medical Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
This page summarizes recall records in which the official source identifies Natus Medical Inc. 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.