Recall Z-2474-2019— B. Braun Medical, Inc.

Name: FDA recall Z-2474-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-10

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2019-07-10, terminated 2020-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191. Reason: The filter capacity is not achieved due to damage of the filter membrane..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-10
Terminated: 2020-08-21
Firm location: Allentown, PA, United States

Product description

CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191

Reason for recall

The filter capacity is not achieved due to damage of the filter membrane.

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