Recall Z-0635-2024— Natus Medical Incorporated

Name: FDA recall Z-0635-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-28

Class II · Ongoing

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2023-11-28. It names one FDA 510(k) clearance: K162437. Product: EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only. Reason: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing..

Recalling firm: Natus Medical Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2023-11-28
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K162437 — Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc.·cleared 2016-10-28

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

EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

Reason for recall

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

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